Not currently registered with FDA under this name

G-C Intl. Corp.

Scottsdale, AZ, United States. Named as applicant on 22 dental 510(k) clearances between 1981 and 1991. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
221981–1991
Markets registered in
1United States
Establishments
0—
1981: 51984: 11985: 31988: 51989: 41990: 21991: 219801990200020102020

510(k) clearances per year, 1980–2026

510(k) clearances

Clearances on which FDA names G-C Intl. Corp. as the applicant.

Decided510(k)DeviceDevice type
27 Dec 1991K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESEJJ Amalgam Alloy
30 Oct 1991K913884FUJI II LCEMA Dental Cement
31 Jul 1990K901999FUJI LINING CEMENT LIGHT CUREEJK Calcium Hydroxide Cavity Liner
6 Jul 1990K896883GC CERVICAL CEMENTEMA Dental Cement
22 Dec 1989K895976TOOTH SHADE RESINEBF Resin Tooth Shade Material
14 Jul 1989K892806TUF-COATELL Porcelain Teeth
1 May 1989K890830DENTURE RESINEBI Rebasing Repairing Relining Denture Resin
17 Apr 1989K890829UNIFAST LCEBG Resin Temporary Crown and Bridge
30 Nov 1988K883770RESUBMITTED EMA DENTIN CEMENTEMA Dental Cement
16 May 1988K880848FUJI CAP II CAPSULE & APPLIEREMA Dental Cement
11 May 1988K880849EXAMIX DISPENSEREKJ Operative Burnisher
18 Apr 1988K880765G-CERA PORCELAIN BONDEBF Resin Tooth Shade Material
12 Apr 1988K880764G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIERELL Porcelain Teeth
1 May 1985K85146976 ELW BITE CHECKER SILICONEELW Impression Material
1 May 1985K85146876 EMA LINING CEMENTEMA Dental Cement
25 Mar 1985K844653LIMI ALLOYEJJ Amalgam Alloy
3 Dec 1984K844329SURFLEX FELW Impression Material
6 Oct 1981K812680G-C IMPRESSION SYRINGEEID Restorative and Impression Material Syringe
6 Oct 1981K812679G-C FIT-CHECKER IMPRESSION MATERIALELW Impression Material
6 Oct 1981K812406EXAFLEX IMPRESSION MATERIALELW Impression Material
25 Sep 1981K812568CAVITRONEMA Dental Cement
26 Jun 1981K811521FUJI IONOMER TYPE I & IIEMA Dental Cement

Some of these clearances are listed with FDA today by another company: GC America Inc. (10).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.