BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES

{0}------------------------------------------------ # K040643 ## APR - 7 2004 ## SECTION I. #### 510(K) SUMMARY | Establishment<br>Information | Brånemark Integration AB<br>1 Lilla Bommen<br>Göteborg, Sweden, SE-411 04<br>Phone: +46 31 760 10 60<br>Fax: +46 31 15 52 60 | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Jan-Olof Djerf<br>Quality Management & Regulatory Affairs, Manager<br>Phone: +46 31 760 10 63 | | Proprietary<br>Device Name | Brånemark Integration Dental Implant and Accessories | | Classification<br>Name | Endosseous Dental Implant (21 CFR 872.3640) | | Device<br>Classification | Class III | | Statement | The information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug, and Cosmetic Act, respecting<br>safety and effectiveness is summarized below. | | Device<br>Description | The Brånemark Integration implant products that are subject of this<br>510(k) are threaded, root-form implants fabricated from<br>commercially pure titanium, and machined and are commercially<br>available. | | Intended<br>Use | The BRÅNEMARK INTEGRATION products are intended for<br>surgical placement into the bone of upper/lower jaw arches as a<br>permanent anchorage for prosthetic devices and to restore chewing | {1}------------------------------------------------ | Indications<br>for use | The Brånemark Integration implants and accessories are subjected for<br>one or two-stage surgical procedures, and either for cemented or<br>screw retained prosthetic restorations. The implants are intended for<br>immediate placement on a single tooth and/or multiple tooth<br>applications recognizing sufficient bone stability (type I or II bone)<br>and appropriate occlusal loading, to restore chewing and speech<br>function. Multiple tooth applications may be connected with a bar. | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | The technological characteristics of the Brånemark Integration<br>implants and accessories remain substantially unchanged from the<br>original Brånemark System® design . No design modifications were<br>made that effect safety and effectiveness. | | Performance<br>Data | Clinical result show that expanded Indications for Use are as safe and<br>effective as the original Indications for Use. | | Conclusion | Based on the 510(k) summaries, 510(k) statements and the<br>information provided in this submission, we conclude that the<br>products are substantially equivalent to currently marketed devices<br>under the Federal Food, Drug and Cosmetic Act. | {2}------------------------------------------------ Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 7 2004 Ms. Jan-Olof Djerf Quality management & Regulatory Affairs, Manager Branemark Integration A.B. Lilla Bommen 1 SE-411 04 Gothenburg SWEDEN Re: K040643 Trade/Device Name: Brånemark Integration Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 5, 2004 Received: March 11, 2004 Dear Ms. Djerf: 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 ahove) 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. {3}------------------------------------------------ Page 2 - Ms. Djerf 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 (301) 594-5613. Also, please note the regulation entitled, "Misoranding 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/dsma/dsmamain.html Sincerely yours, feHWunteshen Image /page/3/Picture/6 description: The image contains a handwritten word, "for", in cursive script. The letters are connected, with the "f" having a prominent loop extending above the baseline and a curved tail extending below. The "o" is a closed oval shape, and the "r" has a short, curved stroke extending from the top of the letter. 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 {4}------------------------------------------------ #### SECTION 2 INDICATIONS FOR USE 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Device Name: Brånemark Integration Endosseous Dental Implant Indications for Use: The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) X Prescription Usc (Pcr 21 CFR 801.109) ાર Over the Counter Use Robert S. Betz, DDS for Dr. S. Runner 510(k) Number: K040643