GC Temp Print

Crown And Bridge, Temporary, Resin

GC America Inc.

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

Pre-market Notification Details

Device IDK193113
510k NumberK193113
Device Name:GC Temp Print
ClassificationCrown And Bridge, Temporary, 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 CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-07-09

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