PROVIPONT C&B

Crown And Bridge, Temporary, Resin

IVOCLAR USA, INC.

The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Provipont C&b.

Pre-market Notification Details

Device IDK941849
510k NumberK941849
Device Name:PROVIPONT C&B
ClassificationCrown And Bridge, Temporary, Resin
Applicant IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst,  NY  14150
ContactLloyd V Ziemendorf
CorrespondentLloyd V Ziemendorf
IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst,  NY  14150
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-14
Decision Date1994-08-17

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