EverX Flow

Material, Tooth Shade, Resin

GC America Inc.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Everx Flow.

Pre-market Notification Details

Device IDK192260
501k NumberK192260
Device Name:EverX Flow
ClassificationMaterial, Tooth Shade, Resin
Applicant GC America Inc. 3737 W. 127th Street Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
GC America Inc. 3737 W. 127th Street Alsip,  IL  60803
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-21
Decision Date2019-11-22

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