510(k) K081818

BIOLOK MICRO-LOK IMPLANT SYSTEM by BioHorizons Implant Systems, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
June 27, 2008
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