FRIOS BONESHIELD

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 7 1998 MAY FRIATEC AG .C/O Mr. Robert Joel Slomoff Consultant to FRIATEC AG Robert Joel Slomoff 9229 Cranford Drive Potomac, Maryland 20854 Re : K973924 Frios Boneshield Trade Name: Requlatory Class: II Product Code: JEY Dated: February 10, 1998 February 10, 1998 Received: Dear Mr. Slomoff: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. - A ----substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Slomoff the Act for devices under the Electronic Product Radiation Che Act for devices and ther Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sisting provilence of your device to a legally Finding of subbeancear equality of a classification for your markets promos, 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 Enclosure {2}------------------------------------------------ 3019831708 FAX NO. FDA/ODE/DDIGD 国口口 P. 2 | Page | of | |------|----| |------|----| K973924 510(k) Number (if k10wn): Friatec Bone Shield Device Name: Indications For Use: The Friatec Bone Shield is indicated for use for insuring three dimensional The I Hates Bons alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Consumence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) '' '' • ﺑﯿﺮ OR Over-The-Counter Use (Optional Format 1-2-96) Susan Penrose (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .