510(k) K103773

ZENOFLEX DIMENSION by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2011
Date Received
December 27, 2010
Clearance Type
Abbreviated
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