510(k) K122269

ENAMIC by Vita Zahnfabrik H.Rauter GmbH & Co. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
July 30, 2012
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