510(k) K152103

IPS Style Ceram, IPS Style Ceram One, IPS Style Press by Ivoclar Vivadent, AG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
July 29, 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