PREMIER SELF-ETCHING ENAMEL SEALANT

K061997 · Premier Dental Products Co. · EBC · Oct 4, 2006 · Dental

Device Facts

• Record ID: K061997
• Device Name: PREMIER SELF-ETCHING ENAMEL SEALANT
• Applicant: Premier Dental Products Co.
• Product Code: EBC · Dental
• Decision Date: Oct 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.

Device Story

Premier Self-Etching Enamel Sealant is a dental material used by clinicians to preventively seal pits and fissures in primary and secondary teeth. It employs a self-etching technique to prepare the enamel surface, eliminating the need for a separate acid-etching step. The material may also be applied as a sealant or lining beneath amalgam restorations. By sealing vulnerable tooth surfaces, the device acts as a physical barrier against caries development. It is intended for professional use in a dental clinic setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pit and fissure sealant and conditioner; self-etching chemical composition; dental material for enamel application; class II device (Product Code EBC).

Indications for Use

Indicated for preventive sealing of pits and fissures in primary and secondary dentition and as a sealant/lining under amalgam restorations.

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

OLT = 4 2006

Mr. Vince Di Alessandro Regulatory Manager Premier Dental Products. Company 1710 Romano Drive Plymouth Meeting. Pennsylvania 19462

Re: K061997

Trade/Device Name: Premier Self-Etching Enamel Scalant Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: Il Product Code: EBC Dated: July 13, 2006 Received: July 14, 2006

Dear Mr. Alessandro:

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 – Mr. Alessandro

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 clectronic 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 vour 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,

C. 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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## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (If known): | \(\) 06 K161647 |
|---------------------------|-----------------|
|---------------------------|-----------------|

Device Name: Premier Self-Etching Enamel Sealant

- Indications for use: Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.
Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mellon for USSR

lesthesiology, General Hospital,

Number: K061997