510(k) K151142

IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID by Wieland Dental + Technik GmbH & Co. KG — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2015
Date Received
April 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type