PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

K012761 · Prime Dental Manufacturing, Inc. · EBC · Nov 1, 2001 · Dental

Device Facts

• Record ID: K012761
• Device Name: PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
• Applicant: Prime Dental Manufacturing, Inc.
• Product Code: EBC · Dental
• Decision Date: Nov 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Prime-Dent® Visible Light Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

Device Story

Prime-Dent Visible Light Cure Pit & Fissure Sealant is a BisGMA-based resin material used by dental professionals in a clinical setting. The device is applied to the occlusal surfaces of primary teeth to seal pits and fissures, acting as a physical barrier to prevent dental caries. The material is cured using a visible light source. By sealing susceptible tooth surfaces, the device aids in the prevention of tooth decay in pediatric patients. It is intended for professional use by dentists or dental hygienists.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

BisGMA-based resin; visible light-cured; supplied in opaque and clear formulations; Class II medical device; product code EBC.

Indications for Use

Indicated for sealing deciduous teeth and filling fissures in primary tooth structure.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

Mr. Roland Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618

Re: K012761

Trade/Device Name: Prime-Dent Visible Light Cure Pit & Fissure Sealant Regulation Number: 872.3765 Regulation Name: Sealant Regulatory Class: II Product Code: EBC Dated: August 14, 2001 Received: August 17, 2001

Dear Mr. Marasigan:

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 approvisions 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 (1 vir 1) vice 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.

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.

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Page 2 - Mr. Marasigan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012761

Indications for Use

Prime-Dent® Visible Light Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

Susan Rummer

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