THE 4.5MM DIAMETER BICON DENTAL IMPLANT

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JAN 1 1 2000 Vincent J. Morgan, D.M.D. President Bicon Dental Implants 1153 Centre Street 02130-3492 Boston, Massachusetts Re: K994037 The 4.5mm Diameter Bicon Dental Implant Trade Name: System Requlatory Class: III Product Code: DZE November 23, 1999 Dated: Received: November 29, 1999 Dear Dr. Morgan: 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 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 (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. ಗೆ 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 requlation may result in requlatory 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 {1}------------------------------------------------ Page 2 - Dr. Morgan obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control 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) 594-4692. 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 Timoth Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ KG94037/A1 Bicon Dental Implants 510 (k) Submission for the 4.5mm Diameter Implant > Page 1 of 1 | 510 (k) Number (IF KNOWN): | K994037 | |----------------------------|--------------------------------| | Device Name: | The 4.5mm Bicon Dental Implant | | Indications for Use: | | The 4.5mm diameter implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridge work , partial dentures, and / or a single tooth replacement. ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 7 OR Over-the-Counter-Use (Optional Format 1-2-96) Susan Runner (Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number