GC PATTERN RESIN

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 Pattern Resin.

Pre-market Notification Details

Device IDK942670
510k NumberK942670
Device Name:GC PATTERN RESIN
ClassificationCrown And Bridge, Temporary, 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 CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-06
Decision Date1994-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6583352051 K942670 000
10386040001038 K942670 000
10386040001045 K942670 000
10386040003414 K942670 000
10386040006682 K942670 000
D6583352011 K942670 000
D6583352021 K942670 000
D6583352031 K942670 000
D6583352041 K942670 000
10386040000949 K942670 000

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