SPI SYSTEM DENTAL IMPLANTS

{0}------------------------------------------------ 510(k) Summary K072649 SPI® System Dental Implants # 510(k) Summary ## Thommen Medical AG SPI® System Dental Implants #### ADMINISTRATIVE INFORMATION Manufacturer Name: Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21 Official Contact: Orlando Antunes Representative/Consultant: Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: 1 (858) 792-1235 Fax: 1 (858) 792-1236 email: lschulz@paxmed.com flarson@paxmed.com #### DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name: Common Name: Classification Regulations: Product Codes Classification Panel: Reviewing Branch: SPI® System Dental Implants Dental implant Endosseous dental implant 21 CFR 872.3640, Class II DZE Dental Products Panel Dental Devices Branch #### INTENDED USE SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. DEC # 6 2007 {1}------------------------------------------------ K072649 SPI® System Dental Implants Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw - - Single-tooth restoration of canines and central incisors in the upper jaw - - Any application involving retentive anchors - #### DEVICE DESCRIPTION Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved. #### EQUIVALENCE TO MARKETED PRODUCT Thommen Medical AG has demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI System Dental Implants are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 0 6 2007 Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130 Rc: K072649 Trade/Device Name: SPI® System Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2007 Received: November 30, 2007 Dear Ms. Schulz: 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. Schulz 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 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, Suite of Michigan Dms. 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}------------------------------------------------ 510(k) Premarket Notification K072649 SPI® System Dental Implants 18/1 ### Indications for Use 510(k) Number (if known): SPI® System Dental Implants Device Name: Indications for Use: SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SPT® CONTACT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw - - -Single-tooth restoration of canines and central incisors in the upper jaw - Any application involving retentive anchors. - Suen (Kusner (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K072649 Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of