PREMIER CERAMIC PRIMER

K131212 · Premier Dental Products Co. · KLE · Aug 26, 2013 · Dental

Device Facts

• Record ID: K131212
• Device Name: PREMIER CERAMIC PRIMER
• Applicant: Premier Dental Products Co.
• Product Code: KLE · Dental
• Decision Date: Aug 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.

Device Story

Premier Ceramic Primer is a one-step silane coupling agent used by dental professionals in clinical settings. It is applied to the surface of ceramic, porcelain, hybrid ceramic, composite resin, or zirconia restorations. The primer chemically modifies the restoration surface to enhance bonding affinity for resin materials. It eliminates the need for mechanical surface preparation like sandblasting or chemical etching. By improving the adhesive interface between the restoration and the cement/resin, the device facilitates secure placement of dental restorations, potentially increasing the longevity and clinical success of the restorative procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

One-step silane coupling agent. Chemical composition designed for surface treatment of porcelain, ceramic, hybrid ceramic, composite resin, and zirconia. Does not require mechanical (sandblasting) or chemical (etchant) pretreatment. Liquid form factor for topical application.

Indications for Use

Indicated for preparation of ceramic materials (porcelain, ceramic, hybrid ceramic, composite resin, zirconia) to improve adhesion to resin materials prior to cementation or restoration. Prescription use only.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2013

Premier Dental Products Company Mr. Vincent D'Alessandro . Regulatory Manager 1710 Romano Drive PLYMOUTH MEETING PA 19462-4500

Re: K131212

Trade/Device Name: Premier Ceramic Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 28, 2013 Received: June 5, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image displays the word "CONFIDENTIAL" in large, bold, black capital letters. The font is sans-serif and the letters are closely spaced together. The word is centered and fills most of the frame, emphasizing its importance.

Image /page/2/Picture/1 description: The image shows the word "premier" in bold, black letters inside of a black, rounded rectangle. The word is white, and the rectangle is black. The word "premier" is written in a sans-serif font.

1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A P: 610-239-6000 / F: 888-773-6872 www.premusa.com

## Indications for Use

510(k) Number (If known): K131212

Device Name: Premier Ceramic Primer

Indications for Use: Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.

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. Prescription Use ___________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S Sheena A. Green -5
2013.08.26 10:54:55 -04:00 -24:20 for M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K131212

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