Bluephase Style 20i

Activator, Ultraviolet, For Polymerization

IVOCLAR VIVADENT, AG

The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Bluephase Style 20i.

Pre-market Notification Details

Device IDK163613
510k NumberK163613
Device Name:Bluephase Style 20i
ClassificationActivator, Ultraviolet, For Polymerization
Applicant IVOCLAR VIVADENT, AG BENDERERSTRASSE 2 Schaan,  LI Fl-9494
ContactSandra Cakebread
CorrespondentDonna Marie Hartnett
IVOCLAR VIVADENT, INC 175 PINEVIEW DRIVE Amherst,  NY  14228
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-22
Decision Date2017-04-04
Summary:summary

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