PREMIER TEMPORARY CEMENT

K051866 · Premier Dental Products Co. · EMA · Sep 6, 2005 · Dental

Device Facts

• Record ID: K051866
• Device Name: PREMIER TEMPORARY CEMENT
• Applicant: Premier Dental Products Co.
• Product Code: EMA · Dental
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.

Device Story

Premier Temporary Cement is a dental material used by dentists for the temporary cementation of crowns, bridges, inlays, and onlays. It functions as a luting agent to secure temporary restorations during the interim period before permanent cementation. The device is applied by the clinician in a dental office setting. It provides temporary retention, allowing for easy removal of the restoration when necessary. It benefits the patient by maintaining the position and function of temporary dental prosthetics during treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement (Product Code EMA). Class II device. Formulated for temporary adhesion of dental prosthetics. No specific material standards, energy sources, or software components described.

Indications for Use

Indicated for the cementation of temporary crowns, bridges, inlays, and onlays in dental patients requiring temporary restorations.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

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

Re: K051866

Trade/Device Name: Premier Temporary Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 8, 2005 Received: July 14, 2005

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 for ans exaction 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 that = Direceal statutes and regulations administered by other Federal agencies. You must or car) i vith 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,

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 Temporary Cement

Indications for use: Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.

x 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)

Sugar Plummer

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

510(k) Number:_

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