510(k) K032302

XIVE TG ABUTMENTS by Friadent GmbH — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2003
Date Received
July 25, 2003
Clearance Type
Traditional
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