Instructions for Use

Select or scroll to review instructions for use for Microcopy products.

NeoDiamond | NeoBurr | NeoDrys | NeoShine | Bite-Chek | Proxi-Chek | Flaps

NeoDiamond

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training in diamond dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Microcopy NeoDiamond burs are manufactured from a single piece of high-quality stainless steel plated at the operational end with a natural diamond grit. The diamond burs are further plated with a unique protective coating formula. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation. These burs are identified as sterile single-use devices and NOT be re-processed and/or re-used. sterile box iconsu icondo not restiril icon

 

INDICATIONS

Microcopy NeoDiamond diamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramics and precious and non-precious alloys.

 

CONTRAINDICATIONS TO USE

Use of Microcopy NeoDiamond is contraindicated on any patient who is allergic to any of the components of the product. Do not reuse. Microcopy NeoDiamond are single-use. Attempts to reuse these products will adversely affect their performance.

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause procedural delays or patient or user injury.
  2. Failure to follow these instructions may cause the following: preparation site damage, injury to the patient or user, or possible aspiration or swallowing of the diamond burs.
  3. Prior to use, carefully inspect the pouch for signs of damage and/or deterioration and check that the expiry date has not expired. Refrain from opening the pouch until you are ready to use the bur.
  4. Prior to use inspect the bur for broken and/or damaged flutes, discard any potentially defective burs. Do not use worn-out or dull devices.
  5. Discard any damaged diamond burs immediately.
  6. Microcopy diamond burs are for SINGLE-PATIENT-USE ONLY. NeoDiamonds are pre-sterilized for single-use and should not be reprocessed or reused.
  7. Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
  8. Protect patient’s eyes and vulnerable tissues when using these diamond burs.
  9. Clinicians should wear eye protection and facemask when using diamond burs.
  10. Surgical masks shall be worn to avoid inhalation of aerosol and/or dust generated during the procedure.
  11. Follow the hand piece manufacturer’s instructions for use and maintenance and service all hand pieces appropriately.
  12. Ensure the bur is fully seated and gripped in the handpiece collet.
  13. Before use, run the handpiece to check for any abnormalities including overheating.
  14. Ensure handpieces are maintained in good working order and remain correctly lubricated at all times.
  15. Move the bur continuously when in use so as to avoid localized heating.
  16. Do not apply excessive pressure on the bur as this could cause undesirable heat and/or may cause the bur to failure.
  17. Move the bur continuously when in use to avoid localized heating and/or damage to the bur. Undesirable heat generation can cause patient discomfort, tooth or tissue necrosis, or patient burns.
  18. Avoid removing the bur at too sharp an angle to avoid leverage and breakage which could cause patient or user injury.
  19. Maintain handpieces in good working condition to ensure maximum effectiveness of the device. Failure to properly maintain handpieces may lead to procedural delays or injury of the patient or user, aspiration or swallowing of the device or damage to the preparation site due to vibration of a worn chuck or turbine.
  20. Ensure the bur is fully seated and securely gripped in the handpiece collet prior to use. Failure to do so may cause the device to “walk out” of the handpiece and may lead to injury of the patient or user or aspiration or swallowing of the device.
  21. Never force a bur into a handpiece as this could cause damage to the handpiece collet which could result in procedural delays.
  22. When using short burs (up to 20mm in length) make certain the head/diamonds to not come in contact with the chucking mechanism.
  23. Short burs are recommended to be used with a mini handpiece.
  24. Always refer to the product packaging for the Maximum RPM. Never exceed the maximum speeds as shown in the table as this may generate undesirable heat.
  25. When cutting off zirconia crowns or using for endo access on zirconia, apply high water spray (>25ml/min) and use a light touch for pressure.
  26. Do not exceed the maximum speeds tabulated below:

 

Instrument head diameter
01/10 (mm) - ISO
Maximum permissible speed
(RPM)
Recommended operational speed
(RPM)
 007 - 010  450,000  100,000 - 220,000
 011 - 014  450,000  70,000 - 220,000
 015 - 018  450,000  55,000 - 160,000
019 - 023 300,000 40,000 - 120,000
024 - 027 160,000 35,000 - 110,000
028 - 031 140,000 30,000 - 95,000
032 - 040 95,000 25,000 - 75,000
041 - 054 95,000 15,000 - 60,000
055 - 070 60,000 12,000 - 40,000
080 - 100 45,000 10,000 - 20,000

 

CLINICAL USE:

Microcopy NeoDiamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel and dentin, dental materials such as composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys. Our range of diamond burs provide maximum cutting efficiency and effortless access through tough diamond for both endodontic treatment and crown removal.

 

Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the handpiece collet. Immediately insert the stem into the handpiece collet and tighten before releasing the grip on the operative end and discarding the empty pouch.

 

STORAGE (PRE-USE):

Store in a dry and clean environment at ambient temperature.
Protect instruments in general against chemicals, acids, heat and extreme temperature variations.

 

STERILE PRODUCT SHELF LIFE:

  • On the provision that appropriate storage and handling practices are applied to all unopened pouches, product sterility will be maintained for five (5) years unless sterile package is opened or damaged. Do not use the product if the package is opened or damaged. do not use icon
  • The products are labeled with their expiry date. Do not use the products after their stated expiration dateuse by icon

 

 TRACEABILITY:

Each package includes Lot number lot icon on its label.

This number must be quoted in any correspondence regarding the product.

 

APPLICABLE SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
do not restiril icon Do not resterilize Indicates a medical device that is not to be re-sterilized.
sterile box icon Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 
lot icon Batch Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
use by icon Use by date Indicates the date after which the medical device is not to be used.
do not use icon Do not use if package is damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
ce icon CE marking Indicates European Conformity Mark.
ec rep Authorized European representative Indicates the Authorized representative in the European Community.
keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
RX DEVICE for professional use only

(ref US FDA CDRH) Indicates device shall only be used by a trained professional.

md Medical Device Indicates device is designed and intended for medical use.
ref Catalog Number Indicates the manufacturer's catalog number so that the medical device can be identified.
1use Single Patient – Multiple Use Indicates a medical device that may be used multiple times in a single operation.
speed Max speed Indicates Max speed
eyeprotect Wear eye protection Indicates that eye protection must be used.
mask Wear a mask Indicates that a face mask must be worn.

 

CONTACT INFORMATION:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

   
ec rep

Obelis S.A
Bd. Général Wahis 53
1030 Brussels, Belgium
Tel:   + (32) 2. 732.59.54
Fax:  +(32) 2.732.60.03
E-Mail: mail@obelis.net

   
ce icon  0483

 

This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.

 

1. Current Valid IFU

NEODIAMOND
IFU for NeoDiamond

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

NeoBurr Carbides

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training in carbide dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Microcopy NeoBurr tungsten carbide burs are manufactured from either a single piece tungsten carbide or, from a tungsten carbide tip, brazed to a surgical grade stainless steel stem. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation  sterile box icon  by a contract sterilizer. These burs are identified as single-use devices and should NOT be re-processed and/or re-used.su icondo not restiril icon

 

INDICATIONS:

Microcopy NeoBurr tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys.

 

CONTRAINDICATIONS TO USE:

Use of Microcopy NeoBurr is contraindicated on any patient who is allergic to any of the components of the product.

Do not reuse. Microcopy NeoBurr are single-use. Attempts to reuse these products will adversely affect their performance.

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause procedural delays or patient or user injury.
  2. Failure to follow these instructions may cause the following: preparation site damage, injury to the patient or user, or possible aspiration or swallowing of the carbide burs.
  3. Prior to use, carefully inspect the pouch for signs of damage and/or deterioration and check that the expiry date has not expired. Refrain from opening the pouch until you are ready to use the bur.
  4. Prior to use inspect the bur for broken and/or damaged flutes, discard any potentially defective burs. Do not use worn-out or dull devices.
  5. Discard any damaged carbide burs immediately.
  6. Microcopy carbide burs are for SINGLE-PATIENT-USE ONLY. Tungsten carbides are pre-sterilized for single-use and should not be reprocessed or reused.
  7. Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
  8. Protect patient’s eyes and vulnerable tissues when using these carbide burs.
  9. Clinicians should wear eye protection and facemask when using carbide burs.
  10. Surgical masks shall be worn to avoid inhalation of aerosol and/or dust generated during the procedure.
  11. Follow the handpiece manufacturer’s instructions for use and maintenance and service all hand pieces appropriately.
  12. Ensure the bur is fully seated and gripped in the handpiece collet.
  13. Before use, run the hand piece to check for any abnormalities including overheating.
  14. Ensure handpieces are maintained in good working order and remain correctly lubricated at all times.
  15. Do not apply excessive pressure on the bur as this could cause undesirable heat and/or may cause the bur to fail.
  16. Move the bur continuously when in use to avoid localized heating and/or damage to the bur. Undesirable heat generation can cause patient discomfort, tooth or tissue necrosis, or patient burns.
  17. Avoid removing the bur at too sharp an angle to avoid leverage and breakage which could cause patient or user injury.
  18. Maintain handpieces in good working condition to ensure maximum effectiveness of the device. Failure to properly maintain handpieces may lead to procedural delays or injury of the patient or user, aspiration or swallowing of the device, or damage to the preparation site due to vibration of a worn chuck or turbine.
  19. Ensure the bur is fully seated and securely gripped in the handpiece collet prior to use. Failure to do so may cause the device to “walk out” of the handpiece and may lead to injury of the patient or user or aspiration or swallowing of the device.
  20. Never force a bur into a handpiece as this could cause damage to the handpiece collet which could result in procedural delays.
  21. Always refer to the product packaging for the Maximum RPM. Never exceed the maximum speeds as shown in the table, as this may generate undesirable heat.
  22. Do not exceed the maximum speeds tabulated below:

 

Instrument head diameter
01/10 (mm) - ISO

Maximum permissible speed
(RPM)

Recommended operational speed
(RPM)
007 - 010 450,000 100,000 - 220,000
011 - 014  450,000 70,000 - 220,000
015 - 018 450,000 55,000 - 160,000
019 - 023  300,000 40,000 - 120,000
024 - 027 160,000 35,000 - 110,000
028 - 031 140,000 30,000 - 95,000
032 - 040  120,000 25,000 - 75,000
041 - 054
95,000 15,000 - 60,000
055 - 070 60,000 12,000 - 40,000
041 - 054 45,000 10,000 - 20,000

 

CLINICAL USE:

Microcopy’s tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic veneers and precious and non-precious alloys. The bur pattern will be selected to cut a specific material in a specific application.

 

Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the hand piece collet. Immediately insert the stem into the handpiece collet and tighten before releasing the grip on the operative end and discarding the empty pouch.

 

STORAGE:

In dry conditions and protected against contaminants. Protect instruments, in general, against chemicals, acids, heat and extreme temperature variations.

 

STERILE PRODUCT SHELF LIFE:

  • On the provision that appropriate storage and handling practices are applied to all unopened pouches, product sterility will be maintained for five (5) years unless sterile package is opened or damaged. Do not use the product if the package is opened or damaged. do not use icon
  • Sterile provided products are labeled with their expiry date. Do-not use the products after their stated expiration date use by icon

 

TRACEABILITY:

Each package includes Lot number lot icon on its label.

This number must be quoted in any correspondence regarding the product.

 

APPLICABLE SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
do not restiril icon Do not resterilize Indicates a medical device that is not to be re-sterilized.
sterile box icon Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 
lot icon Lot Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
use by icon Use By Indicates the date after which the medical device is not to be used.
do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
ce icon CE marking Signifies European technical conformity.
ec rep Authorized European representative Indicates the Authorized representative in the European Community.

 

CONTACT INFORMATION:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

   
ec rep

DENTEQ Medical Technologies
Hafenstrasse 12 76344,
Egenstien-Leopoldshafen, Germany
Fax: +49-7247 944843

   
ce icon  0483

 

This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.

 

1. Current Valid IFU - section for current valid documents.

NEOBURR
IFU for NeoBurr

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

NeoDrys

 CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

The NeoDry products are manufactured in two sizes, Large and Small. The NeoDrys are manufactured with two backing types, Reflective, a metalized film backing, and Original, a white backing. The NeoDrys are used to absorb saliva from the parotid gland. They have a semi-permeable barrier to capture the saliva with super absorbent particles and trap the saliva within the body of the NeoDrys. Within the NeoDrys is a core stiffener to offer cheek retraction as the product expands with saliva.

 

INDICATIONS

The NeoDrys are used to absorb moisture from the parotid gland for up to 15 minutes.  The super absorbent polymer traps moisture as a gel when in contact with saliva.  The NeoDrys core stiffener provides cheek retraction to facilitate procedures far back in the oral cavity.  The NeoDrys backings brighten the oral cavity during procedures and the medical grade poly netting adhere gently to the tissue to stay in place yet removes easily with water spray.

 

CONTRAINDICATIONS TO USE

Use of Microcopy NeoDrys is contraindicated on any patient who is allergic to any of the components of the product.  Do not reuse.  The NeoDrys are single-use.  su icon

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Discard any damaged NeoDrys immediately.
  2. Microcopy NeoDrys are for SINGLE-PATIENT-USE ONLY, in a dental setting.
  3. To remove without tissue irritation, release adhesion with ample water spray to the buccal side of the NeoDrys.
  4. Always keep track of Lot Numbers of NeoDrys to ensure traceability.
  5. Non-toxic by ingestion. If product bursts, remove as much as possible from mouth. Rinse mouth thoroughly with plenty of water. If adverse symptoms appear, seek medical attention.
  6. Always keep track of lot numbers of NeoDrys to ensure traceability. Lot numbers are listed in the format as follows:
    1. Large:L0MMDDYY
    2. Large Reflective:L1MMDDYY
    3. Small:S0MMDDYY
    4. Small Reflective:S1MMDDYY

CLINICAL USE:

Select the NeoDrys size which adequately covers the buccal mucosa.

Step #1 

Insert the NeoDrys as shown with the color side against the cheek.dy ifu1

Point to back of mouth. In a few seconds, NeoDrys will begin to adhere to the tissue and stay in place.dy ifu2

Important: To remove without irritating tissue, release adhesion with ample water spray to the buccal side of the NeoDrys.dy ifu3

 

STORAGE

Microcopy NeoDrys should be stored in a dry, closed container. Improper storage conditions will shorten the shelf life and may cause malfunction of the product

TRACEABILITY

Each package includes Lot numberlot iconon its label.

This number must be quoted in any correspondence regarding the product.

 

SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
lot icon Lot Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
ce icon CE marking Signifies European technical conformity.
 do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
ec rep  Do not use if package is open or damaged

Indicates a medical device that should
not be used if the package has been damaged or opened.

ref Catalog Number Indicates the manufacturer's catalog number so that the medical device can be identified.
manufacture date Date of Manufacture Symbol for date of manufacture.
md Medical Device Indicates device is designed and intended for medical use.
keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
RX DEVICE for professional use only  (ref US FDA CDRH) Indicates device shall only be used by a trained professional. 

 

CONTACT INFORMATION:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

ec rep

Obelis S.A 
Bd. Général Wahis 53
1030 Brussels, Belgium
Tel:   + (32) 2. 732.59.54

ce icon  

 

This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.

1. Current Valid IFU - section for current valid documents.

NEODRYS
IFU for NeoDrys

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

NeoShine Polishers
CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training in rotary polishing. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically. NeoShine polishers are to be used by qualified dental practitioners in dental clinics, hospitals, labs, or schools for dental applications.

 

DESCRIPTION:

Neoshine polishers are single-use abrasive rotary cups or points affixed to a plastic shank. The polishers are individually packaged in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation.sterile box icon

 

INDICATIONS:

NeoShine polishers fit into a slow-speed, contra-angle latch dental handpiece, which provides the rotation, allowing the user to adjust or polish materials both intra-orally and extra-orally, i.e. composite, precious metal, non-precious alloys, amalgam, or zirconia.

 

CONTRAINDICATIONS TO USE:

Use of NeoShine polishers are contraindicated on any patient who is allergic to any of the product components.

In consideration of patient safety, limited extended contact to the mucosa membrane is recommended. These polishers are identified as single-use devices and NOT to be re-process and/or re-sterilize or it will adversely affect their performance. Do not reuse. 

su icondo not restiril icon

COMPONENTS:

Neoshine polishers are available in two (2) geometries: cup and point, which are tailored to polish varying dental restorative substrates as indicated by their name. These materials include Zirconia, Composite, Metal. For each material, two polishing steps are available depending on the desired outcome of polishing. We recommend using the two steps in order to reduce surface roughness and provide the highest amount of shine possible. Composite and Zirconia polishers are designed with a color ID system to aid doctors in selecting the correct polisher. Each substrate has its own color with Composite being gray and Zirconia being magenta. Step 1 is a dark shade and step 2 is a light shade of that color. Metal polishers were designed as Brownies, (step 1), and Greenies, (step 2), which are industry standard. See the below graphic for an illustration of the cup and point geometries as well as an explanation of the polisher steps.

 

NS SPU shapes

Step 1: Satin Polishers:

  • Designed to remove surface striations and anatomical defects.
  • Leaves a smooth, satin-shine surface.

 

Step 2: Hi-Gloss Polishers:

  • Designed to establish a high-gloss surface following the satin polisher.
  • Ideal for anterior and esthetic restorations.

 

PROPER USE:

  • Polishing paste is NOT required.
  • Spray water at least every 10 to 15 seconds to avoid excess heat build-up.
  • These polishers must only be used with dental handpieces (drive unit) that are technically and hygienically maintained.
  • Protective eyewear should be worn at all times. If improperly used, materials can break away and become dangerous flying objects.
  • Wearing a respiratory mask will prevent inhaling dust from polishers.
  • Prior to use, insert the polisher shaft into the driving unit per the driving unit instructions until the polisher is fully seated.
  • Bring polisher to the recommended rotation speed before applying to the surface being treated (reference rotational speed chart below).
  • Improper use of these instruments may lead to poor results and increased patient risk.

 

All Polishers Recommended Speed

Maximum Speed

Pressure

7,000 RPM

20,000 RPM

Step 1: Light
Step 2: Feather Light

 

PRECAUTIONS AND WARNINGS:

ROTATION SPEED

  • Immediately discard any deformed, non-concentric rotating polishers.
  • Never exceed the maximum rotation speed stated.
  • Please refer to the rotation speeds indicated on the product packaging.
  • Failure to observe maximum rotation speeds may cause excessive heat build up resulting in a damaged tooth pulp.
  • Failure to observe recommended rotation speeds can cause vibration and deformation to the polisher which can increase breakage and possible injury.
  • Always keep track of lot numbers of NeoShine to ensure traceability. Lot numbers are listed in the format of PYYMMDD.

 

APPLICATION OF PRESSURE

  • Do not bend the polisher or use it as a lever; doing so increases the risk of breakage.
  • Excessive pressure can cause accelerated deterioration of the polisher.
  • Excessive pressure on the polisher may cause the polisher to break resulting in possible injury.
  • Excessive pressure during use may create excessive heat build up resulting in damage to the tooth pulp.

 

WATER COOLING

  • In order to avoid the overheating of a tooth, sufficient water cooling must be used (50 ml/min). Spray water every 10 to 15 seconds to avoid heat build-up.
  • Insufficient water cooling can lead to irreversible damage to the tooth pulp or its surrounding tissues.
 
STORAGE AND SHELF LIFE
  • Microcopy polishers should be stored in a dry, dark, dust-free environment at 14°F to 122°F (-10°C to 50°C).
    • The polisher box is designed to protect the polishers from sunlight.
    • The polisher pouch is designed to protect the polishers from dust and moisture.
  • Improper storage conditions will shorten the shelf life and may cause product to malfunction.
  • Product sterility will be maintained for four (4) years if appropriate storage and handling practices are observed.use by icon
  • Do NOT use the product if the package is opened or damaged. do not use icon
  • The products are labeled with their expiry date. Do NOT use the products after their stated expiration date.

 

TRACEABILITY

  • Each package include Lot number on its label. lot icon
  • This number must be quoted in any correspondence regarding the product.

 

CONTACT INFORMATION:

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

 

SYMBOLS:

 

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
do not restiril icon Do not resterilize Indicates a medical device that is not to be re-sterilized.
sterile box icon Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 
lot icon Batch Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
use by icon Use By Indicates the date after which the medical device is not to be used.
 do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
 nopaste No polishing paste Indicates polishing paste is not used with these instruments.
 speed Max speed Indicates Max speed
 RX Professional use only (ref US FDA CDRH) Indicates device shall only be used by a trained professional.
 rpm Recommended RPM Indicates Recommended Speed
 eyeprotect Wear eye protection Indicates that eye protection must be used.
 mask Wear a mask Indicates that a face mask must be worn.
 Temp 10 50 Temperature Limit Indicates the upper and lower limits of temperature to which the medical device can be safely exposed.
 light Keep away from sunlight Indicates a medical device that needs protection from light sources
1use Single Patient – Multiple Use Indicates a medical device that may be used multiple times in a single operation.
 su icon Single Patient – Multiple Use Indicates a medical device that may be used multiple times in a single operation.
md  Medical Device Indicates device is designed and intended for medical use.
 keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
ref 

Catalog Number

Indicates the manufacturer's catalog number so that the medical device can be identified.
 ce icon CE marking Signifies European technical conformity.
 ec rep Authorized European representative Indicates the Authorized representative in the European Community.

 

manuf icon  Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144, USA

sales@microcopydental.com
800.235.1863

   
ec rep  Obelis S.A
Bd. Général Wahis 53
1030 Brussels, Belgium

mail@obelis.net
+ (32) 2. 732.59.54

   

 ce icon

 0483

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

1. Current Valid IFU - section for current valid documents.

POLISHERS
IFU for Sterile Dental Polishers

NeoShine Discs
CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training in rotary polishing. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically. NeoShine polishers are to be used by qualified dental practitioners in dental clinics, hospitals, labs, or schools for dental applications.

 

DESCRIPTION:

Microcopy discs are single-use polishers which snap onto a stainless steel re-usable mandrel. These polishers are thin flexible discs and available in two sizes. The devices are intended to remove excessive restorative material and striations. The discs are packed in a plastic tray with a mandrel.

 

INDICATIONS:

NeoShine polishers fit into a slow-speed, right-angle latch dental handpiece, which provides the rotation, allowing the user to adjust or polish materials both intra-orally and extra-orally, i.e. composite, precious metal, non-precious alloys and amalgam.

 

CONTRAINDICATIONS TO USE:

Use of NeoShine polishers are contraindicated on any patient who is allergic to any of the product components. The disc polishers are identified as single-use devices and NOT to be re-processed and/or re-sterilized or it will adversely affect their performance. Do NOT re-use.

 

su icondo not restiril icon

The mandrel is multi-use and may be re-sterilized. The mandrel may be reprocessed a maximum of twenty five (25) cycles.

 

COMPONENTS:

After adjusting restorations use NeoShine polishers in a slow-speed, right-angle handpiece. All disc headpiece products are used as single-patient-use, while the metal mandrel may be re-sterilized and re-used.

DISCS:

  • Designed to remove surface striations and anatomical defects.
  • Leaves a smooth, satin shine surface.
  • Discs have abrasive on one side only.

DiscParts

PROPER USE:

  • Polishing paste is NOT required.
  • Keep the disc dry and cool tooth with air at least
    every 10 to 15 seconds to avoid excess heat build-up.
  • These polishers must only be used with dental handpieces
    (drive unit) that are technically and hygienically maintained.
  • Protective eyewear should be worn at all times. If improperly used, materials can break away and become dangerous flying objects.
  • Wearing a respiratory mask will prevent inhaling dust from polishers.
  • Insert the instrument shaft into the driving unit as far as possible.
  • Unmounted polishers must be centered after shaft mounting in order to avoid vibrations during use.
  • Choose disc for gross reduction of necessary diameter.
  • Place disc for gross reduction by gentle pushing of the connector onto preliminary sterilized mandrel until the disc is securely connected (disc must not wobble on mandrel).
  • Move the disc in one direction: from gingiva towards restoration (back and forth movement over the composite-enamel margin is not recommended).
  • Use discs of all 4 types successively - otherwise the quality of restoration polishing may be reduced.
  • Start polishing at a speed not more than 10,000 rpm. (see chart for recommended speed).
  • Bring polisher to the recommended rotation speed before applying to the surface being treated
  • Improper use of these instruments may lead to poor results and increased patient risk.

 

 

Gross Reduction

Contouring

Finishing

Polishing

Standard Colors Composite Metal

Blue

Pink

Yellow

White

Standard Colors Composite Porcelain

Gray

Blue

Pink

White

Time, seconds

As needed

15 - 20

15 - 20

15 - 20

 

Polisher

Recommended Speed

Maximum Speed

Pressure

Discs

10,000 RPM

30,000 RPM

Light

 

PRECAUTIONS AND WARNINGS:

ROTATION SPEED

  • Immediately discard any deformed, non-concentric rotating polishers.
  • Never exceed the maximum rotation speed stated.
  • Please refer to the rotation speeds indicated on the product packaging.
  • Do not operate mandrel without disc.
  • Avoid contacting of mandrel or disc connector with composite - possible discoloration may require repeating polishing once more.
  • Control quality of disc surface while operating. Rotational behavior and the appearance of the disc changes 10-15 seconds before separation or break. The visual appearance of the disintegrated disc is changed. Do not use discs with delaminated abrasive coating or damaged polymer part. This may cause tissue damage.
  • Do not re-use polishing disc. Second use can lead to:
    • tissue infection,
    • tissue damage caused by delamination of abrasive coating,
    • tissue damage by parts of disintegrated disc,
    • tissue damage caused by disconnection between disc and mandrel.
  • If package with discs or mandrels are broken or disrupted discs or mandrels prior to use must be sterilized by a standard method.
  • Failure to observe maximum rotation speeds may cause excessive heat buildup resulting in a damaged tooth pulp.
  • Failure to observe recommended rotation speeds can cause vibration and deformation to the disc or mandrel which can increase damage and possible injury.
  • Always keep track of lot numbers of NeoShine to ensure traceability. Lot numbers are listed in the format of PYYMMDD.

 

APPLICATION OF PRESSURE

  • Excessive pressure can cause early wear of the polisher.
  • Excessive pressure during use may create excessive heat buildup resulting in damage to the tooth pulp.

 

AIR COOLING:

  • Cool tooth with air at least every 10 to 15 seconds to avoid excess heat build-up.
  • Insufficient air cooling can lead to irreversible damage to the tooth pulp or its surrounding tissues.
 

STORAGE:

  • Store discs and mandrels in a dry place away from direct sunlight. Store within a range of 10°-30°C (50°-86°F).
  • The storage in direct light can cause disc color change and decreased flexibility.

 

PRODUCT SHELF-LIFE:

  • Shelf-life of discs is 5 years since date of production. The expiration date is printed on the label.
  • Shelf-life of mandrels 5 years since date of production 25 or uses.
  • Improper use of these instruments leads to bad quality results and more risks. This is why they must be used only by qualified persons.

 

METHODS OF STERILIZATION

  • Mandrels are sterilized after each patient using either conventional steam autoclave or dry heat sterilizer.
  • Use only sterile or high-quality water for post-rinsing.
  • Dry mandrels thoroughly before sterilization.
  • Do not exceed sterilization temperature of 138°C.
  • Follow instructions of autoclave (sterilizer) manufacturer.
  • In case of risk of disc contamination discs can be sterilized in the following manner:
    • put discs in 2% sodium bicarbonate solution at 70°C for 15 min, mix from time to time,
    • rinse with distilled water,
    • dry at ambient temperature,

 

CLEANING INSTRUCTIONS

PLACE OF USE: No special requirements
STORAGE AND TRANSPORT:

It is recommended to transport the contaminated instruments in a closed container.

It is recommended that instruments be reprocessed as soon as possible, within 2 hours after use at the most. Intermediate storage of used instruments with contamination such as blood residues can lead to corrosion damage.
PREPARATION:

Pre-clean under running water with a brush (plastic) directly after use.

Equipment: plastic brush (e.g. lnterlock, #09084), tap water (20± 2 °C) (at least drinking water quality)

1.  Rinse the polishers under running water for 60 seconds and brush them thoroughly with a plastic brush, particularly the difficult to access areas of the head (bristles, silicone bristle tips).
PRE-TREATMENT:

Pre-clean under running water with a brush (plastic) directly after use.

Equipment: plastic brush (e.g. lnterlock, #09084), tap water (20± 2 °C) (at least drinking water quality)

1.  Rinse the polishers under running water for 60 seconds and brush them thoroughly with a plastic brush, particularly the difficult to access areas of the head (bristles, silicone bristle tips).
CLEANING: MANUAL

Note: Coarse surface contamination on the instruments must be removed before manual reprocessing (see pre-treatment)

Equipment: Multi-stage enzymatic cleaner (e.g. Dürr Dental, ID 215), tap water/flowing water (20± 2 °C) (at least drinking water quality), ultrasonic bath (e.g. Sonorex Digital 10P)

1.  Prepare the cleaning solution according to the manufacturer's instructions (Dürr Dental ID 215 2% solution was validated) and fill into an ultrasonic bath.

2. Completely immerse the polishers in the solution.

3. Expose the products for 1 minute to the ultrasonic bath.

4.  Remove the polishers from the cleaning solution and rinse them each thoroughly (30 seconds) under running water.

5. Check for cleanliness. If contamination is still visible, repeat the above specified steps

 

TRACEABILITY

  • Each package include Lot number on its label. lot icon
  • This number must be quoted in any correspondence regarding the product.

 

SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
do not restiril icon Do not resterilize Indicates a medical device that is not to be re-sterilized.
non sterile Non-Sterile IIndicates a medical device that has not been subject to a sterilization process
lot icon Batch Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
use by icon Use By Indicates the date after which the medical device is not to be used.
 do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
 nopaste No polishing paste Indicates polishing paste is not used with these instruments.
speed Max speed Indicates Max speed
 RX Professional use only (ref US FDA CDRH) Indicates device shall only be used by a trained professional.
 rpm Recommended RPM Indicates Recommended Speed
 eyeprotect Wear eye protection Indicates that eye protection must be used.
 mask Wear a mask Indicates that a face mask must be worn.
 temp Temperature Limit Indicates the upper and lower limits of temperature to which the medical device can be safely exposed.
 light Keep away from sunlight Indicates a medical device that needs protection from light sources
1use Single Patient – Multiple Use Indicates a medical device that may be used multiple times in a single operation.
md  Medical Device Indicates device is designed and intended for medical use.
 keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
ref 

Catalog Number

Indicates the manufacturer's catalog number so that the medical device can be identified.
 ce icon CE marking Signifies European technical conformity.
 ec rep Authorized European representative Indicates the Authorized representative in the European Community.

 

1. Current Valid IFU - section for current valid documents.

POLISHERS
IFU for Non-Sterile Single-Use Disc Polishers

 

manuf icon  Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144, USA

sales@microcopydental.com
800.235.1863

   
ec rep  Obelis S.A
Bd. Général Wahis 53
1030 Brussels, Belgium

mail@obelis.net
+ (32) 2. 732.59.54

   

 ce icon

 0483

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

Bite-Chek

CLINICAL USE:

 

bc ifu

 

1. Dry the tooth surface.
2. Position the film on the teeth.
3. Check occlusion.

 

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Bite-Chek is made up of layers of laminate, ink, paper, medical grade adhesive, and coated film. It is to be used by qualified dental practitioners in dental clinics, hospital, lab, or schools for a dental application. Articulation film is a non-invasive device that can be used on children, adults, adolescents, or animals. Product claims to mark occlusal surfaces or contact points. It is offered as not sterilized; however, it is packaged in a controlled environment. Product is single-use and should NOT be re-processed and/or re-used.

 

INDICATIONS:

Bite-Chek is an articulation film product made to mark the occlusal surface of the mouth. Marking surfaces can include zirconia, porcelain, composite, gold, eMax, or stainless steel.

 

CONTRAINDICATIONS TO USE:

Use of Bite-Chek is contraindicated on any patient who is allergic to any of the components of the product.  Do not reuse.  The Bite-Chek are single-use. su icon

 

CLINICAL PRECAUTIONS AND WARNINGS:

a)     Carefully read package labels to ensure use of the appropriate device.
b)     Failure to follow instructions may cause procedural delays or patient or user injury.
c)      Prior to use, carefully inspect the product for signs of damage and/or deterioration.
d)     Discard any damaged Bite-Chek immediately.
e)     Bite-Chek are for SINGLE-PATIENT-USE ONLY, in a dental setting.
f)      Discard immediately after use.
g)     Always keep track of Lot Numbers of Bite-Chek to ensure traceability.
h)     Used by a trained dental practitioner, assistant, or hygienist.

 

STORAGE:

Bite-Chek should be stored in a dry, dust-free environment, outside of direct sunlight. Improper storage conditions may cause malfunction of the product.

 

TRACEABILITY

Each package includes Lot number lot icon on its label.

This number must be quoted in any correspondence regarding the product.

 

SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
lot icon Lot Code Indicates the manufacturer's batch code so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult the instructions for use. 
ce icon CE marking Signifies European technical conformity.
 do not use icon Do not use if package is open or damaged Indicates a medical device that should not be used if the package has been damaged or opened.
ec rep Do not use if package is open or damaged Indicates a medical device that should not be used if the package has been damaged or opened.

 

CONTACT INFORMATION:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

   
ec rep DENTEQ Medical Technologies
Hafenstrasse 12 76344
Egenstien-Leopoldshafen, Germany
Fax: +49-7247 944843
   
ce icon  

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

1. Current Valid IFU - section for current valid documents.

BITE-CHEK
IFU for Bite-Chek

Proxi-Chek

CLINICAL USE:

 

pc ifu

 

1. Dry prosthesis & tooth surface.
2. For Anterior: use straight. For Posterior: face crease up and pinch down, for two seconds.
3. Release for a 90° angle.
4. Position film next to adjacent teeth & insert prosthesis. Slightly tug to create mark.
5. Remove prosthesis. Adjust at mark. Repeat until it seats.

 

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Proxi-Chek is made up of layers of medical grade laminate, black and cyan ink for print, plastic, medical grade adhesive, and coated film. It is to be used by qualified dental practitioners in dental clinics, hospital, lab, or schools for a dental application. Articulation film is a non-invasive device that can be used on adults, children, and animals. Product claims to mark interproximal surfaces or contact points. It is offered as not sterilized; however, it is packaged in a controlled environment. Product is single-patient-use and should NOT be re-processed.

 

INDICATIONS:

Proxi-Chek is an articulation film product made to assist in the placement of prosthesis. Prosthesis can include crowns, bridges, inlays, onlays, implant crowns, etc. made up of zirconia, porcelain, composite, gold, eMax, or stainless steel.

 

CONTRAINDICATIONS TO USE:

Use of Proxi-Chek is contraindicated on any patient who is allergic to any of the components of the product.  Do not reuse.  The Proxi-Chek is a single-patient-use product.

 

CLINICAL PRECAUTIONS AND WARNINGS:

a)     Carefully read package labels to ensure use of the appropriate device.
b)     Failure to follow instructions may cause procedural delays or patient or user injury.
c)      Prior to use, carefully inspect the product for signs of damage and/or deterioration.
d)     Discard any damaged Proxi-Chek immediately.
e)     Proxi-Chek are for SINGLE-PATIENT-USE ONLY, in a dental setting.
f)      Discard immediately after use.
g)     Always keep track of Lot Numbers of Proxi-Chek to ensure traceability.
h)     Used by a trained dental practitioner.

 

STORAGE:
Proxi-Chek should be stored in a dry, dust-free environment, outside of direct sunlight. Improper storage conditions may cause malfunction of the product.

 

CONTACT INFORMATION:

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

 

SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
lot icon Lot Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
ce icon CE marking Signifies European technical conformity.
 do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

1. Current Valid IFU - section for current valid documents.

PROXI-CHEK
IFU for Proxi-Chek

Flaps

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Flaps products are manufactured in two sizes, Original and Long depending on the size of the patient’s mouth. Flaps are single-use bite tabs for digital sensor and film x-rays which allow the patient to comfortably bite down. Flaps allows full occlusion and visual reference for accurate image positioning and reading. Flaps have an adhesive surface which sticks firmly to the x-ray sensor or film. Flaps are made from soft polyethylene foam and are latex free. They are perfect for horizontal or vertical bitewings, or periapical x-rays using either parallel or bisecting angle technique. Flaps help prevent gagging.

 

INDICATIONS

Flaps are designed to hold and stabilize an x-ray sensor in the patients mouth to make for more accurate readings. Flaps have an adhesive side which sticks to the sensor. The patient is to bite down on the bite-tab with the back of the sensor along their tongue.

 

CONTRAINDICATIONS TO USE

Use of Microcopy Flaps is contraindicated on any patient who is allergic to any of the components of the product. Do not reuse. Flaps are single-use.su icon

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Discard any damaged Flaps immediately.
  2. Microcopy Flaps are for SINGLE-PATIENT-USE ONLY, in a dental setting.
  3. Always keep track of Lot Numbers of Flaps to ensure traceability.
  4. Non-toxic by ingestion. If swallowed by patient, could be a choking hazard. Seek appropriate medical attention.

 

CLINICAL USE:

fl ifu steps

Step #1

  • Stick Flaps on the image side of the x-ray sensor or film. Flaps will adhere to the plastic.

  • Required: snug-fitting sensor protective sheaths!
                                  

Step #2

  • Position the x-ray sensor or film and instruct the patient to bite the Flaps.

 

Horizontal & Vertical Bitewings
Film | Sensor

 

fl ifu periapicals

Posterior & Anterior Periapicals
Film | Sensor

fl ifu periapicals

 

STORAGE

Microcopy’s Flaps should be stored a cool dry environment, with low humidity.

 

TRACEABILITY

Each package includes Lot number on its label.lot icon

This number must be quoted in any correspondence regarding the product.

 

SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
lot icon Lot Code Indicates the manufacturer's batch code so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult the instructions for use. 
ce icon CE marking Signifies European technical conformity.
ec rep Authorized European representative Indicates the Authorized representative in the European Community.
do not use icon Do not use if package is open or damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
ref Catalog Number Indicates the manufacturer's catalog number so that the medical device can be identified.
manufacture date Date of Manufacture Symbol for date of manufacture.
md Medical Device Indicates device is designed and intended for medical use.

 

CONTACT INFORMATION:

manuf icon  Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144, USA

sales@microcopydental.com
800.235.1863

   
ec rep  Obelis S.A
Bd. Général Wahis 53
1030 Brussels, Belgium

mail@obelis.net
+ (32) 2. 732.59.54

   

 ce icon

 0483

 

Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

1. Current Valid IFU - section for current valid documents.

Flaps
IFU for Flaps