SR SPECTRASIT, SR CHROMASIT

Material, Tooth Shade, Resin

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Sr Spectrasit, Sr Chromasit.

Pre-market Notification Details

Device IDK930128
510k NumberK930128
Device Name:SR SPECTRASIT, SR CHROMASIT
ClassificationMaterial, Tooth Shade, Resin
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactLloyd V Ziemendorf
CorrespondentLloyd V Ziemendorf
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-12
Decision Date1993-10-07

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