PREMIER SELF-ETCHING BOND ENHANCER

K061998 · Premier Dental Products Co. · KLE · Oct 4, 2006 · Dental

Device Facts

• Record ID: K061998
• Device Name: PREMIER SELF-ETCHING BOND ENHANCER
• Applicant: Premier Dental Products Co.
• Product Code: KLE · Dental
• Decision Date: Oct 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.

Device Story

Premier Self-Etching Bond Enhancer is a dental adhesive primer/coupling agent; functions as a no-rinse additive to existing bonding systems. Applied by dental professionals in clinical settings to tooth surfaces or restorative materials. Enhances bond strength between composite resins and substrates including enamel, dentin, porcelain, and metal. Facilitates restorative procedures like composite repairs, core build-ups, and cementation of indirect restorations (veneers, onlays, inlays). Improves clinical outcomes by ensuring durable adhesion in restorative dentistry.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental adhesive primer/coupling agent. No-rinse formulation. Designed for compatibility with existing dental bonding agents. Class II medical device.

Indications for Use

Indicated for dental patients requiring adhesive bonding of composite to enamel/dentin, composite/porcelain repair, composite to metal bonding, composite core build-ups, and cementation of veneers, onlays, and inlays. Used as an adjunct to existing dental bonding agents.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cil " & 2006

Mr. Vince D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462-4500

Re: K061998

Trade/Device Name: Premier Self-Etching Bond Enhancer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 13, 2006 Received: July 14, 2006

Dear Mr. D'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. D 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 regencies. 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 807.9). Year 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,

Chiu 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):

DEVICE NAME: Premier Self-Etching Bond Enhancer

INDICATIONS FOR USE: Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.

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)

M.G.G. fa MGR

of Anesthesiology, General Hospital, ontrol, Dental Devices