UNIFIL 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 Unifil Flow.

Pre-market Notification Details

Device IDK020342
510k NumberK020342
Device Name:UNIFIL FLOW
ClassificationMaterial, Tooth Shade, Resin
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry L Joritz
CorrespondentTerry L Joritz
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 Received2002-02-01
Decision Date2002-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14548161075909 K020342 000
14548161075428 K020342 000
14548161075404 K020342 000
14548161075374 K020342 000
14548161075367 K020342 000
14548161075350 K020342 000
14548161075343 K020342 000
04548161073434 K020342 000
04548161073427 K020342 000

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