Instructions for Use

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

NeoDiamond | NeoBurr | NeoDrys | Gazelle | Minnow | 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. 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 variationsIn dry conditions and protected against contaminants.

 

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 ONLY 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

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.

NEODIAMOND
IFU for NeoDiamond

 

2. Archived (previous) IFU's - obsolete versions of the documents.

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 Carbide

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

 

2. Archived (previous) IFU's - obsolete versions of the 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

ndry diagram

 

1. “Ouchless” Comfort Edge®
New technology creates flexible edge with no corners while retaining integrity.

2. Gentle to the Buccal Mucosa
Medical-grade poly netting adheres gently to tissue.

3. Super Absorbent Core
Acrylate polymer retains moisture as a gel when in contact with saliva.

4. Core Stiffener
Poly stiffener insert provides optimum rigidity for cheek retraction.

5. Protective Backing
Choice of ReFlective or Original white backing brightens the oral cavity while providing cheek protection.

{tab=Sizes & Backing}

ndry ls

Color-Coded Sizes
NeoDrys are color coded for quick identification. Available in two sizes: Large (blue) and Small (yellow).
Packaged in convenient easy-to-handle packs of 50 each.

ndry backing

Choice of Backing
Available in ReFlective light-enhancing, mirror-like finish or Original white backing.

{tab=Instructions}

CLINICAL USE:

 

ndrys instructions

Method of Application
Select NeoDrys size which adequately covers the buccal mucosa. Insert as shown
(1) Insert the NeoDrys as shown with the color side against cheek
(2) Point to back of mouth.
In a few seconds, NeoDrys will begin to adhere to the tissue and stay in place.
(3) Important: To remove without irritating tissue, release adhesion with ample water spray to the buccal side of the 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.

 

STORAGE

Microcopy NeoDrys should be stored in a dry, dark, dust-free environment at 2 - 28°C (36 - 82°F). Improper storage conditions will shorten the shelf life and may cause malfunction of the product. The expiration date is printed on the label.

 

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 Prima Dental Group
Stephenson Drive
Gloucester
GL2 2AG, UK
   
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

 

2. Archived (previous) IFU's - obsolete versions of the 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.

Gazelle

CLINICAL USE

Place a composite restoration as you normally would. Shape the occlusal anatomy, fissure pattern and initial contours with a finishing carbide or diamond bur.

Use Microcopy Polishers in a slow-speed, rotary contra-angle handpiece at a maximum speed of 5,000 RPM.
Products are designed to be used dry with intermediate use. To avoid heat build-up, apply water to cool.

 

gz s ifu

 

Step #1 Gazelle Satin Polisher

Removes surface striations and anatomical defects.
Leaves a smooth, satin gloss surface.
Apply light pressure.

 

gz hg ifu

 

Step #2 Hi-Gloss Polisher

Creates an aesthetically smooth surface with a smooth, lustrous, high gloss.
Use feather light pressure to create high gloss shine.

 

  1. Max speed 5,000 rpm.
  2. Use no polishing paste.
  3. Rinse and dry.
  4. For single-patient-use.


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.

 

DESCRIPTION:

Microcopy polishers are abrasive rotary devices affixed to a plastic shank. The devices are indented to remove excessive restorative materials, such as composite. The polisher head is pre-mounted to a shank that is held by a low speed, contra-angle latch dental handpiece. There are various shapes including point, cup, disk, mini-point, and mini-cup. The devices can be used both intra-orally and extra-orally. The polishers are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation  sterile box iconby a contract sterilizer. These burs are identified as single-use devices and NOT be re-processed and/or re-used su icondo not restiril icon

 

INDICATIONS

Microcopy devices fit into a low 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 restorations

 

CONTRAINDICATIONS TO USE

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

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Discard any damaged Polishers immediately.
  2. Microcopy Polishers are for SINGLE-PATIENT-USE ONLY, in a dental setting on teeth or dental restorations.
  3. Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
  4. Do not use worn-out or dull devices
  5. Always refer to the product packaging for the Maximum RPM

• Excessive rotational speed can generate high heat, which may damage the tooth, the surrounding soft tissues, or the restoration. Avoid long periods of applied pressure to avoid heat build up. Apply water spray to cool if needed.

• Operating a polisher or abrasive with too high of an RPM may cause the polisher to fail

  1. Use with slow-speed, rotary contra-angle handpiece only.
  2. Ensure that the Polisher is securely in the chuck of the handpiece, and perform a test run outside of the patient’s mouth before intra-oral use.
  3. Excessive lateral or vertical pressure can damage the Polisher.
  4. Protect patient’s eyes and vulnerable tissues when using these Polishers.
  5. Clinicians should wear eye protection and facemask when using Polishers.
  6. Always keep track of Lot Numbers of Polishers to ensure traceability.
  7. For dentistry use only

 

STORAGE

Microcopy Polishers should be stored in a dry, dark, dust-free environment at 2 - 28°C (36 - 82°F). Improper storage conditions will shorten the shelf life and may cause malfunction of the product. The expiration date is printed on the label.

 

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 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.

 

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.

POLISHERS
IFU for Sterile Dental Polishers

 

2. Archived (previous) IFU's - obsolete versions of the documents.

POLISHERS
IFU for Sterile Dental Polishers

 

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.

Minnow

CLINICAL USE

Place a composite restoration as you normally would. Shape the occlusal anatomy, fissure pattern and initial contours with a finishing carbide or diamond bur.

 

Use Microcopy Polishers in a slow-speed, rotary contra-angle handpiece at a maximum speed of 5,000 RPM.
Products are designed to be used dry with intermediate use. To avoid heat build-up, apply water to cool.

 

mn s ifu

 

Step #1 Satin Polisher

Removes surface striations and anatomical defects.
Leaves a smooth, satin gloss surface.
Apply light pressure.

 

mn hg ifu

 

Step #2 Hi-Gloss Polisher

Creates an aesthetically smooth surface with a smooth, lustrous, high gloss.
Use feather light pressure to create high gloss shine.

 

  1. Max speed 5,000 rpm.
  2. Use no polishing paste.
  3. Rinse and dry.
  4. For single-patient-use.


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.

 

DESCRIPTION:

Microcopy polishers are abrasive rotary devices affixed to a plastic shank. The devices are indented to remove excessive restorative materials, such as composite. The polisher head is pre-mounted to a shank that is held by a low speed, contra-angle latch dental handpiece. There are various shapes including point, cup, disk, mini-point, and mini-cup. The devices can be used both intra-orally and extra-orally. The polishers are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation  sterile box iconby a contract sterilizer. These burs are identified as single-use devices and NOT be re-processed and/or re-used su icondo not restiril icon

 

INDICATIONS

Microcopy devices fit into a low 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 restorations

 

CONTRAINDICATIONS TO USE

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

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Discard any damaged Polishers immediately.
  2. Microcopy Polishers are for SINGLE-PATIENT-USE ONLY, in a dental setting on teeth or dental restorations.
  3. Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
  4. Do not use worn-out or dull devices
  5. Always refer to the product packaging for the Maximum RPM

• Excessive rotational speed can generate high heat, which may damage the tooth, the surrounding soft tissues, or the restoration. Avoid long periods of applied pressure to avoid heat build up. Apply water spray to cool if needed.

• Operating a polisher or abrasive with too high of an RPM may cause the polisher to fail

  1. Use with slow-speed, rotary contra-angle handpiece only.
  2. Ensure that the Polisher is securely in the chuck of the handpiece, and perform a test run outside of the patient’s mouth before intra-oral use.
  3. Excessive lateral or vertical pressure can damage the Polisher.
  4. Protect patient’s eyes and vulnerable tissues when using these Polishers.
  5. Clinicians should wear eye protection and facemask when using Polishers.
  6. Always keep track of Lot Numbers of Polishers to ensure traceability.
  7. For dentistry use only

 

STORAGE

Microcopy Polishers should be stored in a dry, dark, dust-free environment at 2 - 28°C (36 - 82°F). Improper storage conditions will shorten the shelf life and may cause malfunction of the product. The expiration date is printed on the label.

 

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 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.

 

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.

POLISHERS
IFU for Sterile Dental Polishers

 

2. Archived (previous) IFU's - obsolete versions of the documents.

POLISHERS
IFU for Sterile Dental Polishers

 

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  

 

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.

BITE-CHEK
IFU for Bite-Chek

 

2. Archived (previous) IFU's - obsolete versions of the documents.

BITE-CHEK
IFU for Bite-Chek

 

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.

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.

 

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.

PROXI-CHEK
IFU for Proxi-Chek

 

2. Archived (previous) IFU's - obsolete versions of the documents.

PROXI-CHEK
IFU for Proxi-Chek

 

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.

Flaps

Instructions

 

Flaps are perfect for horizontal or vertical bitewings. Excellent for any periapical, using parallel or bisecting angle technique.
Accommodates all #0, #1 and #2 film and sensors.
Required: snug-fitting sensor protective sheaths!

 

Horizontal & Vertical Bitewings
Film | Sensor

fl ifu periapicals

 

Posterior & Anterior Periapicals
Film | Sensor

fl ifu periapicals

        

fl ifu steps

 

1. Stick the Flaps to the back of the film or sensor.

2. Position film or sensor in the mouth for the desired position.

3. Tongue presses against back of film or sensor and teeth bite into center of the Flaps.