GC UNIFAST TRAD

Resin, Denture, Relining, Repairing, Rebasing

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Unifast Trad.

Pre-market Notification Details

Device IDK984365
510k NumberK984365
Device Name:GC UNIFAST TRAD
ClassificationResin, Denture, Relining, Repairing, Rebasing
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 CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-07
Decision Date1999-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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