EASY GLAZE

K082285 · Voco GmbH · EBD · Oct 24, 2008 · Dental

Device Facts

• Record ID: K082285
• Device Name: EASY GLAZE
• Applicant: Voco GmbH
• Product Code: EBD · Dental
• Decision Date: Oct 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

EASY GLAZE is intended for the following applications: 1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations. 2. Sealing the adhesive interfaces between restoration and tooth structure. 3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement. 4. Sealing glass ionomer cement liners/build-up restorations before taking impressions.

Device Story

EASY GLAZE is a nanofilled, light-curing dental coating; provides surface sealing, protection against discoloration, and natural appearance. Applied by dental professionals in clinical settings to provisional/definitive restorations and glass ionomer cements. Polymerized using standard light-curing dental devices. Benefits include moisture protection for glass ionomer cements and improved aesthetic/durability of dental restorations.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by the prior use of components in legally marketed predicate and reference devices.

Technological Characteristics

Nanofilled, light-curing resin coating. Polymerization via external light-curing dental devices. Compositional components are identical to those used in legally marketed predicate devices.

Indications for Use

Indicated for surface sealing of provisional crowns, bridges, glass ionomer cements, and definitive composite restorations; sealing adhesive interfaces between restoration and tooth; protecting glass ionomer surfaces from moisture/dehydration; and sealing glass ionomer liners/build-ups prior to impressions.

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 (K052462)

Reference Devices

• Biscover LV (K043168)
• Ufi Gel SC (K974772)
• Paint-on Polish Agent (K070306)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Manfred Th. Plaumann Contact:

Date prepared: Auqust 04, 2008

EASY GLAZE Trade or proprietary name:

Coating, Filling Material, Resin (872.3310) Classification name:

1:052462 G-Coat Predicate device:

Device description: EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.

EASY GLAZE is intended for the following applications: Intended use:

- 1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
- 2. Sealing the adhesive interfaces between restoration and tooth structure.
- 3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
- 4. Sealing glass ionomer cement liners/build-up restorations before taking impressions.

Technological characteristics: All of the components of EASY GLAZE are found in the legally marketed devices K052462 (G-Coat, the prodicate device), K043168 (Biscover LV Bisco, Inc.) K974772 (Ufi Gel SC, VOCO GmbH) and K070306 (Paint-on Polish Agent, Dentsply International, Inc.).

The prior use of all of the components of EASY GI.AZE in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of EASY GLAZE in legally marketed devices and the performance data and results provided support the safety and effectiveness of EASY GLAZE for the intended use

VOCO GmbH, August 04th, 2008

Manfred Th. Plaumann Managing Board

OCT 2 4 2008

7-1

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strabe 1-3 27472 Cuxhaven GERMANY

OCT 2 4 2008

Re: K082285

Trade/Device Name: EASY GLAZE Regulation Number: 872.3310 Regulation Name: Coating Material for resin fillings Regulatory Class: II Product Code: EBD Dated: August 6. 2008 Received: August 11, 2008

Dear Dr. Gerkensmeier:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Gerkensmeier

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours,

J.H. Samuels Jr. for all

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number: | K0082285 |
|----------------|----------|
|----------------|----------|

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

EASY GLAZE is intended for the following applications:

- 1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
- 2. Sealing the adhesive interfaces between restoration and tooth structure.
- 3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
- 4 Sealing glass innomer cement liners/build-u restorations before taking impressions.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suver Qusra

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Reviews Division of Antrol, Dental Devices

510(k) Number: K082285