510(k) K151490

PRETTAU ANTERIOR T0 by Zirkonzahn GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2015
Date Received
June 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type