Medical Device Manufacturer · US , Alsip , IL

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

125 submissions · 125 cleared · Since 1993

125

Total

125

Cleared

0

Denied

125 devices

76-100 of 125

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

Cleared Jun 25, 1998

GC FUJI ORTHO LC

Cleared Jun 16, 1998

GC FUJI BOND LC

Cleared Jun 01, 1998

MIRACLE MIX CAPSULE

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