ABUTMENT - COMPLETE

{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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Jack T. Krauser, D.M.D. The Implant Center of The Palm Beaches 824 US Highway I, Suite 370 North Palm Beach, Florida 33408 FEB 20 1998 K974280 Re : Abutment - Complete Trade Name: Regulatory Class: III Product Code: DZE October 20, 1997 ... .. . Dated: November 5, 1997 Received: ## Dear Dr. Krauser: 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 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 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 current Good Manufacturing Practice requirement, as set --forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 {1}------------------------------------------------ Page 2 - Dr. Krauser not affect any 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 requlations. 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 regulation (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.fdaggov/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}------------------------------------------------ 1974280 of Page | 510(k) Number (if known): | K97-4280 | |---------------------------|----------| |---------------------------|----------| Abutment Device Name: Indications For Use: The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Conci rrence of CDRH, Office of Device Evaluation (ODE) 2974280 - Suan Runas (Division Sign-Off) (Division Sign-Off, Division of De and General I 510(k) Numb Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)