ZYGOMA IMPLANT (IMMEDIATE FUNCTION)

{0}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness 1.4 | Submitted by: | Herbert Crane<br>Director Regulatory Affairs | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | | Telephone: | (714) 282-4800, ext. 5074 | | Facsimile: | (714) 282-9023 | | Date of Submission: | January 17, 2007 | | Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) | | Trade or Proprietary<br>or Model Name: | Zygoma Implant | | Legally Marketed Device(s): | Branemark System Zygomaticus Fixture System (K970499)<br>Zygoma TiUnite (K050641)<br>Zygoma Angled Abutments (K052885) | ## Device Description: The Zygoma Implant is a titanium endosseous implant longer than traditional endosseous implants. The Zygoma Implant is intended to extend through the maxillary sinus into the Zygomaticus bone. The Zygoma Implant is particularly useful when there is insufficient bone for a traditional implant. ## Indications for Use: Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. The text is written in all capital letters. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 4 - 2007 Nobel Biocare AB C/O Mr. Herbert Crane Director, Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887 Re: K070182 Trade/Device Name: Zygoma Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE Dated: January 17, 2007 Received: January 19, 2007 Dear Mr. Crane: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Crane Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Suity Y Mohammd Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K070182 510(k) Number (if known): Device Name: Zygoma Implant Indications For Use: Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kei Mulvey for M SR on of Anesthealalogy, General Hespital ol, Dental Devices Page 1 of 1