510(k) K070601

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM by Intra-Lock International — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2007
Date Received
March 2, 2007
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