510(k) K101913

ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM by Anthogyr Sas — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
July 8, 2010
Clearance Type
Abbreviated
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