510(k) K120198

LOCATOR OVERDENTURE IMPLANT SYSTEM by Zest Anchors, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
January 23, 2012
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