BASIC Dental Implant System Post and Core - Thin Attachment

BASIC Dental Implant System Post and Core - Thin Attachment
Statement Letter:
Mr. Dan Blacklock
Vice President
BASIC Dental Implant Systems, Incorporated
3321 Columbia NE
Albuquerque, New Mexico 871 07
Re: KO22912
Trade/Device Name: BASIC Dental Implant System Post & Core-Thin Attachment
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: August 28. 2002
Received: September 3, 2002
Dear Mr. Blacklock:
We have reviewed your Section 5 1 O(k) preinarket 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 coininerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have bcen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a preniarket 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 nia-ior regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts SO0 to 898. In addition, I:DA may publish fiirther announccnients concerning your device in the Federal Registcr.
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 ActÇƒÙs 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 (2 1 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 classificatioii 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) 594-4611. 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, Çƒ?Misbranding by reference to premarket notificationÇƒ? (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. fda. qov/cdrh/dsma/dsmamain. html
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Anesthesiology, General Hospital.
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Applicant: BASIC Dental Implant Systems, Inc.
Address: 3321 Columbia NE
Albuquerque, New Mexico 87107
USA
Contact Person: Dan Blacklock, Vice-president
Telephone / Fax / Email :
505.881.1376- Phone
505.884.1923 -Fax
Preparation Date: August 28,2002
Device Trade Name: BASIC Dental Implant System Post and Core - Thin
Attachment
Common Name: Accessory to a Dental Implant
Description of the Post and Core - Thin Attachment: The Post and Core - Thin Attachment is a one-piece
attachment. The base is cemented into a dental implant. Artificial teeth are then attached to the Post and Core - Thin using conventional techniques.
Intended use: The Post and Core - Thin Attachment is intended to attach artificial teeth to a dental implant.