VARIOUS DENTAL IMPLANTS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and two lines representing its legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Grundy Advanced Biomedical Systems LLC C/O Mr. William Simmons Vice President Technical Support 832 Marseilles - Galion RDW Marion, Ohio 43302 IJUL 2 8 2010 Re: K100411 Trade/Device Name: Bioesthetic Dental Implant 4,2 - 3,5 Series Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 20, 2010 Received: July 23, 2010 Dear Mr. William Simmons: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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. {1}------------------------------------------------ ## Page 2- Mr. Simmons 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. f ally a Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {2}------------------------------------------------ INDICATIONS FOR USE 510(K) NUMBER(IF KNOWN): K100411 DEVICE NAME: BIOESTHETIC DENTAL IMPLANT 4,2-3,5 SERIES INDICATIONS FOR USE: THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT. AND/OR PRESCRIPTION USE X (PART21 CFR 801 SUBPART D) OVER-THE-COUNTERUSE (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) Kevin Mulby for MSR (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices GE1 OF 1 510(k) Number: K100411