IPS E.max One

Powder, Porcelain

Ivoclar Vivadent AG

The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max One.

Pre-market Notification Details

Device IDK211916
510k NumberK211916
Device Name:IPS E.max One
ClassificationPowder, Porcelain
Applicant Ivoclar Vivadent AG Bendererstrasse 2 Schaan,  LI Fl-9494
ContactSandra Cakebread
CorrespondentAnderjeet Gulati
Ivoclar Vivadent Inc 175 Pineview Drive Amherst,  NY  14228
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-08-20

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