BRANEMARK SYSTEM(R) EBON(TM) FIXTURE

{0}------------------------------------------------ Pre-market Notification Page -3-***************************************************************************************************************************************************************************** Ka7482y ## VII. 510(k) Summary of Safety and Effectiveness MAR 2 4 1998 A. Name and Address This Summary of Satety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs. B. Name of the Device This device system consists of various titanium fixtures and two drills. C. The Predicate Product The predicate products used in this Pre-market Notification are other components marketed by Nobel Biocare which include the self-tapping MKII fixtures DCA 220, DCA 222, DCA 224, DCA 666, DCA 765 (K945398). D. Description of Device The Nobel Biocare Ebon Fixture™ is an endosseous implant made of grade 1 commercially available titanium and is intended to be placed in the upper or lower jaw bone to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This system also includes 2 bevel drills. E. Intended Use of the Device Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patients chewing function. This fixture is not intended for use in Type I bone. F. Comparison of Technological Characteristics The technological characteristics between the components of the Branemark System® Ebon Fixtures and the corresponding predicate products found in the Branemark System® are identical. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure. The design is composed of several curved lines that create a sense of movement and dynamism. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 4 1998 Ms. Betsy A. Brown ·Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 Westmont, Illinois 60559 Re : K974828 Trade Name: Branemark System® Ebon™ Fixture Regulatory Class: III Product Code: DZE Dated: December 23, 1997 Received: December 24, 1997 Dear Ms. Brown: 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. ਚ substantially equivalent determination assumes compliance with --the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 {2}------------------------------------------------ Page 2 - Ms. Brown 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 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.fdal.gov/cdrh/dsmamain.html". Sincerely yours, Tim R. Whiteley thy A. Ulatows Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | 510(k) Number (if known): | | |---------------------------|--------------------------------| | Device Name: | Branemark System® Ebon Fixture | Indications For Use: Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This fixture is not intended for use in type I bone. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ka 7458 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)