ACE ALVEOLAR DISTRACTOR

{0}------------------------------------------------ Image /page/0/Picture/2 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 symbol of three human profiles facing to the right, with flowing lines representing movement or progress. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 6 1998 NOV J. Edward Carchidi, D.D.S. President Ace Surgical Supply Company, Incorporated 1034 Pearl Street P.O. Box 1710 Brockton, Massachusetts 02403 K981526 Re : Ace Alveolar Distractor Trade Name: Requlatory Class: II Product Code: JEY Dated: August 10, 1998 Received: August 11, 1998 Dear Dr. Carchidi: 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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. {1}------------------------------------------------ Page 2 - Dr. Carchidi 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) 594-4692. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Susan Runyon Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | 1 | ------- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | 510(k) Number (if known): Device Name: Indications For Use: Re: K981526 ## Indications for Use Indications: The ACE Surgical Alveolar Distraction Fixture is designed for use in totally edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE Surgical Alveolar Distractor. This ACE Surgical transitory monofocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Contraindications: The ACE Surgical Alveolar Distraction Fixture is contraindicated in patients with insufficient available bone, poor bone quality, and generalized diseases, allergies or habits (uncontrolled diabetes, blood dycrasias, hyperthyroidism, AlDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene, etc.) that may contribute to poor healing or osteogenesis formation of bone. The patient's good medical health status and history is mandatory. In addition, a radiographic evaluation to examine the anatomical condition of the patient for proper use of the device to the defined surgical protocol is required. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number