TEMPOSIL, MODEL 6720

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure. MAR 1 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Coltene/Whaledent AG C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128 Re: K050426 Trade/Device Name: TempoSil Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 17, 2005 Received: February 18, 2005 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 ass batted in also increations and 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 frant of other of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 – Mr. Henry J. Vogelstein Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1177 s 155dailed of a vace ince complies with other requirements of the Act or that FDA made a decemination that your certify of ther Federal agencies. You must comply with any Federal statutes and regulations administration of to: registration and listing (21 CFR Part 807); an the Act s requirements; morading; base ring practice requirements as set forth in the quality labeling (21 CFR Part 801), good manazave.org from if applicable, the electronic product radiation systems (QB) regallers (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) I ms letter whil anow you to oegin manteting your antial equivalence of your device to a legally premarked notification: "The PDF mailig of bation 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 If you desire specific daries in: Joan at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphilance an (21 CFR Part 807.97). You may obtain other Mission of reference to promobilities under the Act from the Division of Small general international on your copyright in the many of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Suyette Michie, Om.D. Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ **coltène** **whaledent** Coltène/Whaledent AG 510(k) Submission TempoSil Indications for use ## Indications for use 510(k) Number (if known): more |(05 0 426 Device Name: TempoSil and/or Indications for use: - temporary cementing of temporary crowns and bridges - temporary cementing of final restorations Prescription Use: __ × (21 CFR Part 801 Subpart D) Over-the Counter Use: _ (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Russer al Ser Off on of Ancoflestology, General Hospital, Jon Control, Dental Devices 10 100 KOS 04264260