OCO Dental Implant (5.0 mm Diameter)

OCO Dental Implant (5.0 mm Diameter)
Statement Letter Only:
Mr. David D. Dalise
President
Çƒ?0Çƒ? Company, Incorporated
600 Paisano NE. Suite A
Albuquerque, New Mexico 87123
Re: KO23336
Trade/Device Name: OCO Dental Implant (5.0 mm Diameter)
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: September 27, 2002
Received: October 7, 2002
Dear Mr. Dalise:
We have reviewed your Section 5 1 O(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 accordaiice 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.
If your device is classified (see above) into either class I1 (Special Controls) or class 111 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDAÇƒÙs issuance of-a substantial equivalence dctcrmination docs not mean that FDA has made a determination that your device complies :it11 other t-equircmetits of the Act or any Federal statutes and regulations administered by othcr 1:ederal 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); 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 53 1-542 of' thc Act). 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 1 O(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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (2 1 CFR Part 807.97). Other general information on your responsibilities under
the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http: //www. fda. qov/cdrh/dsma/dsmamain. h t m l
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological I-Iealth