EDOSSEOUS DENTAL IMPLANT

{0} K970127 JUN 23 1997 # Calcitek HA-Coated Endosseous Dental Implants January 1997 ## 510(k) SUMMARY ### INFORMATION - RELEASABLE THROUGH FOI Summary of Information Concerning Safety and Effectiveness for Purposes of establishing Substantial to a Predicate Device Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended. | Company Name: | Calcitek, Inc. | | --- | --- | | Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 | | Telephone Number: | (619) 431-9515 | | Registration Number: | 2023141 | | Contact Person: | Donna K. Howard | | Date Summary Prepared: | December 1996 | | Classification Name: | Implant, Endosseous (76DZE) | | --- | --- | | Common/Usual Name: | Dental Implant System | | Device Trade Name: | Calcitek HA-Coated Endosseous Dental Implant Systems | The primary devices used for comparison purposes in this summary are Calcitek's existing HA-coated endosseous dental implant systems. All implant systems are manufactured in the same facility located in Carlsbad, California. 1. **Intended Use:** The statements of intended use are identical. "For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement." 2. **Description:** These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. 3. **Technological Characteristics** **Design:** There has been no change to the design of these implants. **Materials:** The materials used for the dental implants are the same as previously mentioned in the premarket notifications. 510(K) SUMMARY INFORMATION - Releasable through FOI 092-4 EO'd 928-1 E5161E7091 XELIOYD:MOA 06:21 16 IN MAY {1} 092-1 70'd 928-1 2526187092 11111111111111111111111111111 # Calcitek HA-Coated Endosseous Dental Implants January 1997 ## 4. Comparison Analysis: The overall design of the implants is identical to the predicate devices. The composition of the HA coating has been changed. the crystalline HA content has been enhanced and the content of all non-HA components has been decreased. 510(K) SUMMARY INFORMATION - Releasable through FOI {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 23 1997 Ms. Donna K. Howard Supervisor, Clinical Affairs Sulzer Calcitek Incorporated 2320 Faraday Avenue Carlsbad, California 92008-7216 Re: K970127 Trade Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: January 10, 1997 Received: January 14, 1997 Dear Ms. Howard: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3} Page 2 - Ms. Howard This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} Page 1 of 1 510(k) Number (if known): K970127 Device Name: HA coated Endosseous Dental Implant Indications For Use: Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Suse Rensselaer Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K970127 Prescription Use 2/2 (Per 21 CFR 801.100) OR Over-The-Counter Use 2/2 (Optional Format 1-2-96)