510(k) K143090

LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID by Talladium, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2015
Date Received
October 28, 2014
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