RELIEF ACP ORAL CARE GEL

K062176 · Discus Dental, Inc. · LBH · Jan 10, 2007 · Dental

Device Facts

• Record ID: K062176
• Device Name: RELIEF ACP ORAL CARE GEL
• Applicant: Discus Dental, Inc.
• Product Code: LBH · Dental
• Decision Date: Jan 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.

Device Story

Relief ACP Oral Care Gel is a topical dental product applied to teeth to alleviate dentin sensitivity. It functions by forming a protective layer of calcium phosphate and potassium nitrate on the tooth surface. The gel is intended for use by patients to manage sensitivity discomfort. It is applied directly to the affected areas of the teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical gel formulation containing calcium phosphate and potassium nitrate. Classified as a cavity varnish under 21 CFR 872.3260.

Indications for Use

Indicated for patients experiencing dentin sensitivity discomfort.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven L. Ziemba Vice-President, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City, California 90232

Re: K062176

Trade/Device Name: Relief ACP Oral Care Gel Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 8, 2007 Received: January 9, 2007

Dear Mr. Ziemba:

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.

JAN 1 0 2007

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 – Mr. Ziemba –

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" (21CFR Part 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.

Chih-Lin, Ph.D.

Chiu Lin. Ph.D. 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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## E. Indications for Use Statement

**510(k) Number:** K062176

:

Device Name: Relief ACP Oral Care Gel

## Intended Use

Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth. 1:00 pm 1 personal program and .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>Per 21 CFR Section 801.109) | OR | Over-The-Counter Use __________ |
|-------------------------------------------------|----|---------------------------------|
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*Super*
n of Anesthesiology, General Hospital,
on Control, Dental Devices
K062176
Discus Dental, Inc. 510(k) for Relief Gel
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CONFIDENTIAL