TETRIC FLOW

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 Tetric Flow.

Pre-market Notification Details

Device IDK993783
510k NumberK993783
Device Name:TETRIC FLOW
ClassificationMaterial, Tooth Shade, Resin
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactPeter P Mancuso
CorrespondentPeter P Mancuso
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 Received1999-11-08
Decision Date1999-12-13

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