COE COMFORT

K070698 · GC America, Inc. · EBI · Mar 29, 2007 · Dental

Device Facts

• Record ID: K070698
• Device Name: COE COMFORT
• Applicant: GC America, Inc.
• Product Code: EBI · Dental
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.

Device Story

Coe Comfort is a dental material used for relining ill-fitting dentures, creating functional impressions for full dentures, constructing obturators, and lining surgical/periodontal splints. It also serves as a diagnostic aid to identify pressure points on dentures. The material is applied by dental professionals in a clinical setting. It functions as a tissue-conditioning or impression material, allowing the clinician to adjust denture fit or capture anatomical detail. By improving denture adaptation and identifying pressure areas, the device aids in patient comfort and prosthetic stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Product code EBI. Class II device.

Indications for Use

Indicated for patients requiring denture relining, functional impressions for full dentures, obturator construction, surgical/periodontal splint lining, and diagnostic pressure area localization on dentures.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry L. Joritz-Lyons Director - Regulatory Affairs and Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

MAR 2 9 2007

Re: K070698

Trade/Device Name: Coe Comfort Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 08, 2007 Received: March 15, 2007

Dear Ms. Joritz-Lyons:

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). Your over, 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 mey publish further 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 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 yours,

Syltie Y. Michaud, M.D.

Čhiu 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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## Indications for Use

## 510(k) Number (if known): K070698

Device Name: Coe Comfort

## Indications for Use:

Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suver Runser

n of Anesthesiology, General Hospital cion Control, Dental Devices

510(k) Number: K670698

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