3A Dental Implant System - 510K Submissions

3A Dental Implant System
Statement Letter
Osseco Biosource, Limited
C/O Ms. Michele H. Vovolka
Vantage Consulting International, Litimed
P.O. Box 848
Grayslake, Illinois 60030
Re: KO1 1879
Trade/Device Name: 3A Dental Implant System
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: May 27,2002
Received: May 29,2002
Dear Ms. Vovolka:
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 accordance 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 I11 (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 determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 1 CFR Part 807); labeling (2 1 CFR Part 80 1); 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 the 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 (2 1 CFR Part 80 1 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 h t t p : //www. f da . qov/cdrh/dsma/dsmamain. html
Director'
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Infection Control and Dental Devices
Summary Information
Osseco Biosource, Ltd.
64 Old Orchard, Suite 320
Skokie, Illinois 60077
Michele H. Vovolka
Vantage Consulting International, Ltd
847-856-03 5 5
847-8 56-03 5 7
May 29,2001
3A Dental Implant System
Endosseous Implant
Endosseous Implant
Class 111 per 21 CFR 872.3640
Brinemark Nobel Biocare
IT1 Dental Implant System
Description:
The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or textured (abrasive blasted). The implants are available in various insertion lengths and diameters
Intended Uses/Indications:
The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.