XiVE@ 3.0 Dental Implant System

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Summary Only:
SUBMITTER INFORMATION
Company Name: FRIADENT GmbH.
Company Address: Steinzeugstrasse 50
Mannheim D-68229
Germany
Company Phone: (01 1) 49 06 21 4 86 1549
(01 1) 49 06 21 4 86 1866 Company Facsimile:
Contact Person: Heike Dietzler
Regulatory Affairs Manager
Date Summary Prepared: February 27,2003
DEVICE IDENTIFICATION
TradeRroprietary Name: XiVE@ 3.0 Dental Implant System
Classification Name: Endosseous Dental Implants
21 CFR 872.3640
DEVICE DESCRIPTION
The XiVE 3 .O Dental Implant System consists of subgingival threaded dental implants with a 3.25mm diameter and lengths of 1 1 - l5mm . The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and
prosthetic components. The system is designed for two stage procedures for single tooth replacement in the anterior regions of the mouth.
INTENDED USE
The XiVE 3.0 Dental Implant System is indicated for single tooth restorations in the region of 7 to 10 and 23 to 26.