SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S

Denture, Plastic, Teeth

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Sr Vivodent S, Sr Orthotyp S, Sr Ortholingual S.

Pre-market Notification Details

Device IDK132984
510k NumberK132984
Device Name:SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
ClassificationDenture, Plastic, Teeth
Applicant IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactDonna Marie Hartnett
CorrespondentDonna Marie Hartnett
IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeELM  
CFR Regulation Number872.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-24
Decision Date2014-01-14
Summary:summary

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