AMERICAN DENTAL IMPLANT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 1 2004 Mr. Steven B. Lombardi President American Dental Implant Corporation 2415 Wilmington Road New Castle, Pennsylvania 16105 Re: K042462 Trade/Device Name: American Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 25, 2004 Received: September 10, 2004 Dear Mr. Lombardi: We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed yound 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 merslate commerce prior ve been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 00d, Drag, and Stou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providers or 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 (1 Wr ), it may of bagyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or rounder announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Lombardi Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that 1 DTC issualites of that your device complies with other requirements meall that IDA has mass a deceminary administered by other Federal agencies. of the Act of ally I edelar status and registered to registering but not limited to: registration You must comply with an the Her b required (21 CFR Part 801); good manufacturing practice alld listing (21 CF R F rut 007), labeling (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (Sections 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) This letter will anow you to begal finding of substantial equivalence of your device to a premitser notification. The PDF masults 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), If you desire specific at no to for your at (301) 594-4613. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Russo 1 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __ K042462__________________________________________________________________________________________________________________________________________ Implant, Endosseous, Root-Form________________________________________________________________________________________________________________________________________________ Device Name: The American Dental Implant is intended to be surgically placed in Indications for Use: the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) comments of the consisted in the many commended for consistence for control controlled and consistences Susan Rumse (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division of Anesthesiology, General Devices Division of Anesthoolones, Infection Control, Devices Page 6 (a) KOUDJOG 510(k) Number: _