GDLS-200

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 Gdls-200.

Pre-market Notification Details

Device IDK082434
510k NumberK082434
Device Name:GDLS-200
ClassificationMaterial, Tooth Shade, Resin
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-25
Decision Date2008-11-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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