G-COAT

K052462 · GC America, Inc. · EBD · Oct 20, 2005 · Dental

Device Facts

• Record ID: K052462
• Device Name: G-COAT
• Applicant: GC America, Inc.
• Product Code: EBD · Dental
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.

Device Story

G-Coat is a dental surface sealant applied to direct composite, glass-ionomer, and indirect composite restorations, including provisional restorations. It functions by sealing the restoration surface and the adhesive interface between the restoration margin and the tooth structure (enamel or dentin). The device is intended for professional use by dentists in a clinical setting. By sealing these interfaces, the device aims to reduce microleakage and improve the longevity and marginal integrity of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Coating material for resin fillings (21 CFR 872.3310). Product code EBD. Class II device.

Indications for Use

Indicated for sealing surfaces of direct composite, glass-ionomer, and indirect composite restorations, as well as provisional restorations and their adhesive margins to enamel or dentin.

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.

Submission Summary (Full Text)

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OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ms. Terry L. Joritz-Lyons Director - Customer Care Group GC America, Inc. 3737 West 127th Street Alsip, Illinois 60803

Re: K052462

Trade/Device Name: G-Coat Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: August 19, 2005 Received: September 12, 2005

Dear Ms. Joritz-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 510(t) production is substantially equivalent (for the indications for referenced above and nave acternillied are e devices marketed in interstate commerce use stated in the encrosure) to regally man of the Medical Device Amendments, or to devices that proof to May 26, 1970, fire chaolinens and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance was a proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, sabject erequirements for annual registration, listing of devices, good Controls provisions of the reville, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (360 above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish fourther announcements concerning your device in the Federal Register

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## Page 2 - Ms. Terry L. Joritz-Lyons

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r touse of advisod that I 27 rination that your device complies with other requirements of the Act or that I Drived a accessions administered by other Federal agencies. You must comply with all 1 caeral surface and regarding, but not limited to: registration and listing (21 CFR Part 807); an the Ave requirements as a manufacturing practice requirements as set forth in the quality laboring (21 CFR Part 800); 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) I his letter wiff anow your to ough finding of substantial equivalence of your device to a legally prematicated predicated. - The slassification 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other IMisoranding of televisibilities under the Act from the Division of Small general 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 yours,

Susa Kunor

Zita S. Luki, Ph.D.

Chiu S. Lin, PhD 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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510(k) Number (if known):

Device Name: G-Coat

Indications For Use:

To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Conner

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K052462

Prescription Use
(Per 21 CFR 801.109 ✓

OR

Over-The-Counter Use ----------

(Optional Format 1-2-96)