4.0MM SIMPLER THREADED DENTAL IMPLANT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 27 1998 Dr. Harold Bergman ·President Vancouver Implant Resources, Incorporated 2370 Maple Street Vancouver, BC Canada, V6J 3T6 Re : K974857 4.0MM Simpler Threaded Dental Implant Trade Name: III Requlatory Class: Product Code: DZE Dated: December 18, 1997 Received: December 29, 1997 Dear Dr. Bergman: 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, Druq, 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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A --substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 {1}------------------------------------------------ Page 2 - Dr. Bergman through 542 of the Act for devices under the Electronic enrough SIL or one instrul provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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}------------------------------------------------ K974857/A1 Page__________________________________________________________________________________________________________________________________________________________________________ | 510(k) Number (if known): | K974857 | |---------------------------|----------------------------------------| | Device Name: | 4.0 mm Simpler Threaded Dental Implant | | Indications for use: | | For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth. RECEIVED 30 JAN 98 14056 FDA/CDRH/ODE/BMC ## (PLEASE DO NOT WRITE BELOW THIS LINE) Concurrence of CDRH, Office of Device Evaluation (ODE)  (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ____________________ | Prescription Use | <i>yes</i> | OR | Over-The-Counter Use | <i>no</i> | |----------------------|------------|----|-------------------------|-----------| | (Per 21 CFR 801.105) | | | (Optional Format 1-2-9) | | (Optional Format 1-2-96)