S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three lines representing the eagle's head and neck. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 1 2001 Dr. Christian Bottcher Regulatory Compliance Officer S & C Polymer GmbH Silicon-Und Composite Spezialitate Robert-Bosch-Strabe 5 Elmshorn, GERMANY Re: K012767 Trade/Device Name: S & C Hydro Vinyl Polysiloxane Impression Material Regulation Number: 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: August 14, 2001 Received: August 17, 2001 Dear Dr. Bottcher: 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. Please be advised that FDA's issuance of a substantial equivalence determination does not {1}------------------------------------------------ ## Page 2 - Dr. Bottcher 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## 9. Statement of Indications for Use ## NOV 0 1 2001 510(k) Number (if known): K012767 Device Name: Indications for Use: S & C Hydro Vinyl Polysiloxane Impression Material S & C Hydro Vinyl Polysiloxane Impression Material is intended to be placed into a syringe for delivery around a tooth or on a preformed impression tray for placement in the mouth, and used to reproduce the structure of a patient's teeth and gums. Concurrence of CDRH, Office of Device Evaluation (ODE) Suen Roon Firm Sign-Off) sion of Dental, Infection Control, Ceneral Hospita Com Number . Prescription Use: or