IMPLANT SITE DILATORS

{0}------------------------------------------------ BioHorizons Implant Systems, Inc. 510(k) Notification January 28, 1998 K980874 MAR - 4 1998 # 510(k) Summary of Safety and Effectiveness #### Proprietary Name Implant Site Dilators Common Name Osteotomes ## Classification Name Dental Surgical Instruments ## Classification Class III (revised 24Feb98) #### Official Contact Winston Greer, VP of Operations and Director of Quality Assurance BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, Alabama 35209 (205) 871-1345 Fax (205) 870-0304 ## Device Description The Implant Site Dilators are hand-operated instruments which provide an aid in the placement of root form implants in soft maxillary bone. All components are made from surgical grade stainless steel. ## Product Evaluation The BioHorizons Implant Site Dilators have been evaluated in laboratory conditions and by consulting implantologists and oral and maxillofacial surgeons. These evaluations indicate that the Implant Site Dilators should be safe and effective when used as intended. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked vertically and slightly offset from each other. The profiles are abstract and formed by curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 4 1998 Mr. Winston Greer Vice President of Operations & Director of Quality Assurance BioHorizons Implant Systems, Incorporated 2129 Montgomery Highway Birmingham, Alabama 35209 Re: K980374 Trade Name: Implant Site Dilators Regulatory Class: III Product Code: DZE Dated: January 28, 1998 Received: January 30, 1998 Dear Mr. Greer: 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 {2}------------------------------------------------ Page 2 - Mr. Greer through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 gener 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timot Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ BioHorizons Implant Site Dilators Device Name: Indications for Use: * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * BioHorizons Implant Site Dilators are indicated for use to aid in the placement of root form implants in soft maxillary bone. Rather than removing valuable bone from the surgical site, the function of these instruments is to manually form the osteotomy by compressing the bone laterally, causing a denser bone to implant interface. ## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Peaser (Division Sign-Off) (Division Sign-On) Division of Dental, Infection Control, and General Hospity OxC 510(k) Number Prescription Use (per 21 CFR 801.109) OR Over-The-Counter Use Page 28