Branemark- Integration Dental Implant and Accessories

Branemark- Integration Dental Implant and Accessories
Statement Letter:
Ms. Jan-Olof Djerf
Quality management & Regulatory Affairs, Manager
Branemark Integration A.B.
Lilla Bommen 1
SE-411 04 Gothenburg
SWEDEN
Re: K040643
Trade/Device Name: Brinemark Integration Endosseous Dental Implant
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: III
Product Code: DZE
Dated: March 5, 2004
Received: March 11, 2004
Dear Ms. Djerf:
We have reviewed your Section 5 1 0(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 II (Special Controls) or class III (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 FDA's 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 (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 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) 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), please conta ct the Office of Compliance at (301) 594-5613. 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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
Summary Information
Establishment Branerrark Integration AB
Information 1 Lilla Bomnmen
Gbteborg, Sweden, SE-411 04
Phone: +46 31 760 1060
Fax: 迂46 31 15 5260
Contact Jan-01of Djerf
QUality Management & Regulatory Affairs, Manager
Phone: 迂46 31 760 10 63
Proprietary Br~nemark- Integration Dental Implant and Accessories
Device Name
Classification Name Endosseous Dental Implant (21 CFR 872.3640)
Device Classification: Class III
Statement The information Supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below.
Device Description
The Branerrark Integration imiplant products that are Subject of this 5 1 0(k) are threaded, root-Ibrm implants fabricated from commercially pure titanium, and machined and are commercially available.
Intended Use:
The BRANEMARK INTEGRATION products are intended for surgical placement into the bone Of upper/lower jaw arches as a permanent anchoragye for prosthetic devices and to restore chewing
function.
Conclusion
Based on the 5 10(k) summaries, 510(k) statements and the information provided in this submission, we conclude that the products are substantially equivalent to currently marketed devices under the Federal Food, Drug and Cosmetic Act.