OPTIGLAZE COLOR

K133836 · GC America, Inc. · EBD · Mar 6, 2014 · Dental

Device Facts

• Record ID: K133836
• Device Name: OPTIGLAZE COLOR
• Applicant: GC America, Inc.
• Product Code: EBD · Dental
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth. For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.

Device Story

Optiglaze Color is a light-cured resin material used by dental professionals to characterize and glaze dental restorations. It is applied to direct and indirect composite restorations, acrylic denture bases, and artificial acrylic teeth. The device is supplied in 17 shades and is applied using a brush to the surface of the restoration after contouring. Once applied, the material is polymerized using a visible light-curing device. The output is a hardened, characterized, and smooth surface layer that provides improved wear resistance and aesthetic customization. The device is intended for use in a clinical or laboratory setting by dental practitioners.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with specifications for appearance, depth of cure, color stability after irradiation, surface hardness, and application characteristics.

Technological Characteristics

Light-cured resin coating material. Composition: multifunctional acrylate, methyl methacrylate, amorphous fumed silica filler, photo-initiator, and pigments. Polymerization via photo-initiator system triggered by visible light. Form factor: liquid in bottles/kits with brushes. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for characterization and surface finishing of direct/indirect composite restorations, acrylic denture bases, and artificial acrylic teeth to improve smoothness and wear resistance.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• G-Coat (K133836)

Submission Summary (Full Text)

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KI33836

Section 5 - 510(k) Summary

Image /page/0/Picture/2 description: The image shows the text "MAR - 6 2014" in the upper portion of the image. Below the date is the text "CCI" in a bold, sans-serif font. The text is black and the background is white.

GC AMERICA INC..

3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL [phone]
FAX [phone]
www.gcamerica.com

- 1. Submitter Information:
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

| Contact Person: | Mark Heiss, D.D.S. |
|-----------------|--------------------|
| Phone: | [phone] |
| Fax: | [phone] |

Date Prepared: December 13, 2013

- 2. Device Name ..

| Proprietary Name: | Optiglaze Color |
|------------------------|----------------------------------|
| Classification Name: | Coating, Filling Material, Resin |
| Device Classification: | Class II, 872.3310 |
| Product Code: | EBD |

- Predicate Devices: 3.

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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IN LAND SER E E E LAND SERVED LAUN<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>FINALERS CLASS CLASS COLLECT CAME CA<br>AND OF CHININGS CHARACT CHARACT COLLEGIAL COLLEGIAL COLLEGION COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT CARD AND<br>. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | C<br>---------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

- Description of Device: 4.
- 5. Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.
- 6. Indications for Use:
- For characterization of direct and indirect composite restorations, acrylic denture base and a. artificial acrylic teeth.
- b. For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.

## 7. Technological characteristics:

All the components of the applicant device, Optiglaze Color, have already been used in the predicate devices. The curing mechanism of the predicate devices is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.

- 8. Substantial equivalence:
The applicant device complies with all the requirements of ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation & testing.

The curing mechanism of the new and predicate devices is substantially equivalent in principle. Therefore, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices.

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- . 9. Differences
The following differences may be noted between the predicate device and Optiglaze Color: · Optiglaze Color has higher surface hardness and comes in multiple shades.

- 10. Performance Bench Tests
It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:

- Appearance .
- Depth of cure ●
- Color stability after irradiation �
- Surface hardness �
- Application characteristics .
- ਉਂ Packaging

Complete set: A-Plus 2.6ml, B-Plus 2.6ml, C-Plus 2.6ml, White 2.6ml, Ivory-White 2.6ml, Yellow 2.6ml, Orange 2.6ml, Pink-Orange 2.6ml, Pink 2.6ml, Red-Brown 2.6ml, Olive 2.6ml, Lavender 2.6ml, Grey 2.6ml, Blue 2.6ml, Red 2.6ml, Clear 5ml, Clear HV 5ml

Accessories Disposable Pallet Flat Brush Round Brush Brush Holder Box

- 10. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 3 years -
- Store in a cool and dark place. 4-25°C (39.2 77.0°F)

| | Applicant device | Comparative device |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>category | Coating, Filling Material, Resin, Class II | Coating, Filling Material, Resin, Class II |
| Trade name | OPTIGLAZE COLOR | G-Coat |
| Manufacturer | GC Corporation | GC Corporation |
| Intended use | For characterization of restorations<br>made of composite resins & acrylics.<br>For obtaining surface smoothness and<br>wear resistance of restorations made of<br>composite resins & acrylics. | Used to seal the surface of followings to protect<br>from moisture and dehydration, and to provide<br>an extra smooth surface gloss: direct composite<br>and glass-ionomer restorations, indirect<br>composite restorations, provisional restorations,<br>and their adhesive interface of margin to<br>enamel or dentin. |
| Product<br>description | OPTIGLAZE COLOR is a light-cured<br>glazing and characterizing material for<br>such restorations as direct and indirect<br>composite resins & acrylics. | G-COAT is a light-cured protective coating<br>agent to be used to seal the surface of such<br>restorations as direct or indirect composites,<br>glass-ionomer restorations, provisional and the<br>interface between those restorations and<br>enamel or dentine. The coated surface<br>presents high smoothness, and it may reduce<br>or even eliminate the need for manual<br>polishing. |

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| | | polishing. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Multifunctional acrylate.<br>Methyl methacrylate.<br>Silica filler (amorphous, fumed).<br>Photo initiator.<br>Pigment. | Multifunctional methacrylate.<br>Methyl methacrylate.<br>Silica filler (amorphous, fumed).<br>Photo initiator. |
| Instructions for<br>use | 1) After contouring the resin surface,<br>finish with a carbide bur or coarse<br>silicone point.<br>2) Wash and dry the surface.<br>3) Apply a thin layer to the resin surface<br>using the brush provided.<br>4) Light cure with LaboLight LV-3 or<br>equivalent halogen light for 5 minutes. | a) Contour restoration according to the<br>manufacturer's instructions.<br>b) Clean the restoration and adjacent surfaces<br>to be coated with pumice and water.<br>c) Rinse and dry.<br>d) Using a cotton pellet or brush apply G-COA<br>to all exposed restoration and adjacent surface<br>e) Light cure for 20 seconds using suitable<br>visible light curing device.<br>f) Close bottle immediately after use. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 6, 2014

GC AMERICA INCORPORATED Dr. Mark Heiss, D.D.S. 3737 W. 127th Street Alsip, IL 60803

Re: K133836

Trade/Device Name: OPTIGLAZE COLOR Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: II Product Code: EBD Dated: December 13, 2013 Received: December 18, 2013

Dear Dr. Heiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Dr. Heiss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

Indications for Use

135836 510(k) Number (if known):

Device Name: Optiglaze Color

Indications for Use:

- 1. For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- 2. For obtaining surface smoothness and wear resistance of restorations made of composite. resin, acrylic denture base and artificial acrylic teeth.

Prescription Use _ ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Runner -S -05,00,

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