XiVE@ TG Dental Implant System

XiVE@ TG Dental Implant System
Statement Letter:
FRIADENT GmbH
C/O Ms. Carol Patterson
Patterson Consulting Group, Incorporated
2191 1 Erie Lane
Lake Forest, California 92630
Re: KO32284
Trademevice Name: XiVE@ TG Dental Implant System
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: July 22,2003
Received: July 24,2003
Dear Ms. Patterson:
We have reviewed your Section 5 1 O(k) premarket ndfication 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 ActÇƒÙs 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 10(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 (30 1) 594-46 13. Also, please note the regulation entitled, Çƒ?Misbranding by reference to premarket notificationÇƒ? (2 1 CFR 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,
Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
SUBMltTTER INFORMATION
CompanyName: FRZADENT GmbH.
Company Address: Steinzuegstrasse
Mannheim D-68229
Germany
Company Phone: (011)496214302 1121
(01 1) 49 621 43 02 2121 Company Facsimile:
Contact Person: Heike Dietzler
Regulatory Affairs Manager
Date Summary Prepared: July 22,2003
TradeLProprietary Name: XiVE@ TG Dental Implant System
Classification Name: Endosseous Dental Implants 21 CFR 872.3640
DEVICE DESCRIPTION
The XiVE TG Dental fmplant System consists of transgingival threaded dental implants in 3.4 -4Smm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surfixe MZ.1. The XiVE* TG Dental Implant System is comprised of dental implants, surgical and labratory instruments and prosthetic components. The system is designed for single stage procedures for splinted crowns, bridges and complete dentures. In the edentulous mandible, the XVE@ TG transgingival dental implants are indicated for immediate loading procedures using the standard protocol.
INTENDED USE
The XiVE TG ental bplant System is indicated for single-stage implant placement, with a minimum healing phase of h e months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported
by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentuolous mandible, a minimum of four XiVE* TG transgingival dental implants (>0.5mm length) are placed between the
mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
CONCLUSIONS
This notification cootajns all Xotmation required by 21 CFR 807.87. A completed copy of the premarket Notification 5 1O(k) Reviewer's Checklist is provided in this submission. Performance evaluations of the XiVE TG dental implant system show that the device performs as intended. Comparison of the
XiVE TG dental implant system to the predicate devices show tha the device is substantially equivalent. The complete swface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File.