SOLOCEM

{0}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### January 8, 2013 Mr. Silke Wallaschek Head Regulatory Affairs Colténe/Whaledent AG Feldwiesenstrasse 20 Altstatten St. Gallen, Switzerland 9450 Re: K121621 Trade/Device Name: SoloCem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: П Product Code: EMA Dated: November 19, 2012 Received: November 21, 2012 #### Dear Mr. Wallaschek: 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. {1}------------------------------------------------ Page 2 – Mr. Wallaschek 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Anthem La m Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {2}------------------------------------------------ ### Section 4 - Indications for Use Statement 510(k) Submission SoloCem # Indications for Use 510(k) Number (if known): K121621 Device Name: SoloCem Indications for Use: SoloCem is indicated for - permanent cementation of root posts of all types - permanent cementation of crowns, bridges, inlays, onlays - permanent cementation of 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) 2013.01.04 Susan Runner DDS, MA 12:46:41 -02,00, (Division Sign-Off) (Division Sign-Off) Division of Anestheslology, General Hospital Martian Control, Dental Devices Division of Anesthestology, Or k121621 510(k) Number: Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Altstätten Switzerland Phone +41 (0)71 757 53 00 Fax +41(0)71 757 53 10 e-mail : info.ch@coltene.com