510(k) K032284

XIVE TG DENTAL IMPLANT SYSTEM by Friadent GmbH — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2003
Date Received
July 24, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type