ANKYLOS¨? Dental Implant System

ANKYLOS¨? Dental Implant System
Statement Letter:
FRIADENT GmbH
C/O Ms. Carol Patterson
Patterson Consulting Group, Incorporated
21911 Erie Lane
Lake Forest, California 92630
Re: K041509
Trade/Device Name: ANKYLOS¨? Dental Implant System
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: II
Product Code: DZE
Dated: August 13, 2004
Received: August 17, 2004
Dear Ms. Patterson:
We have reviewed your Section 510(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 11 (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 contact the Office of Compliance 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 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,
1Chi Lin, Pli.D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information
SUBMITTER INFORMATION
a. Company Name: FRIADENT GmbH.
b. Company Address: Steinzeugstrasse 50
Mannheim D-68229
Germany
Company Phone: (011) 49 621 43 02 1121
Company Facsimile: (011) 49 621 43 02 2121
Contact Person: Heike Dietzler
Regulatory Affairs Manager
Date Summary Prepared: May 24, 2004
DEVICE IDENTIFICATION
a. Trade/Proprietary Name: ANKYLOS¨? Dental Implant System
b. Classification Name: Endosseous Dental Implants
21 CFR 872.3640
IDENTIFICATION OF PREDICATE DEVICES
Company Device 510(k) No. Date Cleared
FRIADENT GmbH ANKYLOS¨? K012087 08/22/2003
Dental Implant System
FRIADENT GtnbH XiVE¨? K032 158 08/14/2003
Dental Implant System
FRtADENT GmbH] YiVE¨? K021318 07/02/2002
Dental lImplant System
FRIADENT GmbHl ANKYLOS¨? Dental Implant System
Original Premarket 510(k) Notification
DEVICE DESCRIPTION
The ANKYLOS¨? Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS¨? Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is
designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANKYLOS¨? dental implants are indicated for immediate loading procedures using the standard protocol.
INTENDED USE
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for
transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
CONCLUSIONS
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 5 10(k) Reviewer's Checklist is provided in this submission. Performance evaluations of the ANKYLOS¨? dental implant system show that the device performs as intended. Comparison of the
ANKYLOS¨?~~ dental implant system to the predicate devices shows that the device is substantially equivalent. The complete surface characterization of the FRIADENT Surface has been detailed in a Device Master File.