ANKYLOS DENTAL IMPLANT SYSTEM

{0}------------------------------------------------ K040946 JUL 0 1 2004 #### SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15: This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. #### SUBMITTER INFORMATION 15.1 | a. | Company Name: | FRIADENT GmbH. | |----|--------------------------------------|------------------------------------------------------| | b. | Company Address: | Steinzeugstrasse 50<br>Mannheim D-68229<br>Germany | | c. | Company Phone:<br>Company Facsimile: | (011) 49 06 21 4 86 1549<br>(011) 49 06 21 4 86 1866 | | d. | Contact Person: | Heike Dietzler<br>Regulatory Affairs Manager | | e. | Date Summary Prepared: | April 7, 2004 | | | DEVICE IDENTIFICATION | | | a. | Trade/Proprietary Name: | ANKYLOS® Dental Implant System | | b. Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 | |-------------------------|-----------------------------------------------| |-------------------------|-----------------------------------------------| #### 15.3 IDENTIFICATION OF PREDICATE DEVICES | Company | Device | 510(k) No. | Date Cleared | |------------------|-----------------------------------|------------|--------------| | Dentsply Ceramco | ANKYLOS® Dental Implant<br>System | K012681 | 08/22/2003 | #### 15.4 DEVICE DESCRIPTION 15.2. The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling. {1}------------------------------------------------ K040946 # SUBSTANTIAL EQUIVALENCE ાર્સ્ડ The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and indications for use. #### 15.6 INTENDED USE The ANKYLOS® dental implant is an endosseous dental implant that is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient's must be subject for dental treatment with endosseous implants. #### 15.7 TECHNOLOGICAL CHARACTERISTICS The technological characteristics of the ANKYLOS® Dental Implant System have not changed with the additional of the new labeling. # 15.8 CLASS III CERTIFICATION AND SUMMARY This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act. # 15.9 CONCLUSIONS This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewers Checklist is provided in this submission. Comparison of the ANKYLOS dental implant systems to the predicate device show that the device is substantially equivalent. {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 a stylized image of an eagle or bird-like figure with three wing-like shapes above a wavy line, representing water or movement. JUL 0 1 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FRIADENT GmbH C/O Ms. Carol Patterson President Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630 Re: K040946 Trade/Device Name: ANKYLOS® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 7, 2004 Received: April 12, 2004 Dear Ms. Patterson: 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. {3}------------------------------------------------ # Page 2 - Ms. Patterson 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) 594-4613. 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/dsma/dsmamain.html Sincerely yours, 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}------------------------------------------------ # INDICATION FOR USE K040946 510(k) Number: Device Name: ANKYLOS® Dental Implant System Indications for Use: An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Penner (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number: | K040946 | |----------------|---------| |----------------|---------| | Prescription Use | <div>✓</div> | OR | Over-The-Counter Use | | |------------------|--------------|----|----------------------|--| |------------------|--------------|----|----------------------|--| (Per 21 CFR 801.109)CONFIDENTIAL