Medical Device Manufacturer · US , Alsip , IL

GC America, Inc. - FDA 510(k) Cleared Devices

128 submissions · 128 cleared · Since 1993

128

Total

128

Cleared

0

Denied

128 devices

76-100 of 128

Cleared Feb 02, 2004

Cleared Oct 20, 2003

Cleared Jan 30, 2003

Cleared Jan 22, 2003

Cleared Jan 16, 2003

TEMPORARY CEMENT-DC010002

Cleared Oct 18, 2002

Cleared May 03, 2002

GC ELITE CEMENT 100

Cleared Apr 26, 2002

GC FUJI ORTHO BAND PASTE PAK

Cleared Mar 28, 2002

Cleared Feb 28, 2002

GC FUJI LINING LC PASTE PAK

Cleared Feb 20, 2002

Cleared Oct 29, 2001

FUJI VII CAPSULE

Cleared Oct 16, 2001

Cleared Aug 07, 2001

Cleared Jan 16, 2001

Cleared Aug 16, 2000

Cleared Jul 17, 2000

Cleared Jul 05, 2000

Cleared Jan 27, 2000

AROMA FINE (NORMAL AND FAST SET)

Cleared Jan 11, 2000

FUJI II LC CAPSULE

Cleared Jul 09, 1999

ACRON MC MODIFICATION

Cleared May 28, 1999

GC RELINE SOFT/EXTRA SOFT

Cleared Feb 25, 1999

GC UNIFAST TRAD

Cleared Feb 04, 1999

MIRACLE MIX POWDER/LIQUID

Cleared Oct 19, 1998

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Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026