Medical Device Manufacturer · US , Walker , MI

G-C Intl. Corp. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1981

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - G-C Intl. Corp. Dental ✕

22 devices

1-22 of 22

Cleared Dec 27, 1991

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES

Cleared Oct 30, 1991

Cleared Jul 31, 1990

FUJI LINING CEMENT LIGHT CURE

Cleared Jul 06, 1990

GC CERVICAL CEMENT

Cleared Dec 22, 1989

TOOTH SHADE RESIN

Cleared Jul 14, 1989

Cleared May 01, 1989

Cleared Apr 17, 1989

Cleared Nov 30, 1988

RESUBMITTED EMA DENTIN CEMENT

Cleared May 16, 1988

FUJI CAP II CAPSULE & APPLIER

Cleared May 11, 1988

EXAMIX DISPENSER

Cleared Apr 18, 1988

G-CERA PORCELAIN BOND

Cleared Apr 12, 1988

G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER

Cleared May 01, 1985

76 EMA LINING CEMENT

Cleared May 01, 1985

76 ELW BITE CHECKER SILICONE

Cleared Mar 25, 1985

Cleared Dec 03, 1984

Cleared Oct 06, 1981

EXAFLEX IMPRESSION MATERIAL

Cleared Oct 06, 1981

G-C FIT-CHECKER IMPRESSION MATERIAL

Cleared Oct 06, 1981

G-C IMPRESSION SYRINGE

Cleared Sep 25, 1981

Cleared Jun 26, 1981

FUJI IONOMER TYPE I & II