510(k) K112710

ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2011
Date Received
September 19, 2011
Clearance Type
Special
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