TEMPOSIL 2

K083304 · Coltene/Whaledent AG · EMA · Feb 6, 2009 · Dental

Device Facts

• Record ID: K083304
• Device Name: TEMPOSIL 2
• Applicant: Coltene/Whaledent AG
• Product Code: EMA · Dental
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TempoSIL 2 is indicated for - temporary cementation of provisional restorations - temporary cementation of provisional restorations on implant abutments - temporary cementation of final crown and bridges - temporary cementation of final crowns and bridges on implant abutments

Device Story

TempoSIL 2 is a dental cement used by dentists for the temporary fixation of provisional or final restorations, including crowns, bridges, and implant abutments. It is a material-based device applied clinically to secure dental prosthetics temporarily. It functions as a luting agent to provide retention while allowing for future removal of the restoration. No complex electronics, software, or algorithms are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental cement; chemical composition typical of temporary luting agents; supplied for professional dental use; non-electronic; no software.

Indications for Use

Indicated for temporary cementation of provisional or final crowns, bridges, and implant abutments in dental patients.

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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB - 6 2009

Coltene/Whaledent AG C/o Mr. Henry J. Vogelstein 1349 Lexington Avenue New York, New York 10128

Re: K083304

> Trade/Device Name: Temposil 2 Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: November 7, 2008 Received: November 10, 2008

Dear Mr. Vogelstein:

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. Vogelstein

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Ginette V. Michael, MP

Ginette Y. Michaud, M.D. Acting 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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#### bection 4 - Inclications for Use Statement

K083304

# Indications for Use

510(k) Number (if known):

Device Name:

TempoSIL 2

Indications for Use:

TempoSIL 2 is indicated for

- temporary cementation of provisional restorations
- temporary cementation of provisional restorations on implant abutments
- temporary cementation of final crown and bridges
- temporary cementation of final crowns and bridges on implant abutments

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *X*
(Part 21 CFR 801.109)

AND/OR

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

..

Suka Bume

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K953304

Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Altstätten Switzerland Phone [phone] Fax [phone] E-mail [e-mail]