IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE

Material, Tooth Shade, Resin

IVOCLAR VIVADENT AG

The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips Empress Direct Color Ips Empress Direct Opaque.

Pre-market Notification Details

Device IDK121230
510k NumberK121230
Device Name:IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
ClassificationMaterial, Tooth Shade, Resin
Applicant IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan,  LI Fl-9494
ContactSandra Cakebread
CorrespondentSandra Cakebread
IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan,  LI Fl-9494
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-24
Decision Date2012-08-29

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