SYSTEMP.C&B PLUS

Crown And Bridge, Temporary, Resin

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Systemp.c&b Plus.

Pre-market Notification Details

Device IDK042820
510k NumberK042820
Device Name:SYSTEMP.C&B PLUS
ClassificationCrown And Bridge, Temporary, Resin
Applicant IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactDonna Hartnett
CorrespondentDonna Hartnett
IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-12
Decision Date2004-12-14

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