GC RELINE

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 Reline.

Pre-market Notification Details

Device IDK982695
510k NumberK982695
Device Name:GC RELINE
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 Received1998-08-03
Decision Date1998-10-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10386040007078 K982695 000
10386040003766 K982695 000
10386040000871 K982695 000

Trademark Results [GC RELINE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GC RELINE
GC RELINE
75854069 2479267 Live/Registered
TRADEMARK HOLDINGS OF ILLINOIS LLC
1999-11-19

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