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

51-75 of 125

Cleared Feb 15, 2008

GC MODELS OPA-100 AND JC-50

Cleared Feb 14, 2008

GC AADVA ABUTMENT

Cleared Aug 09, 2007

Cleared May 15, 2007

Cleared Apr 12, 2007

GC MI PASTE PLUS

Cleared Mar 29, 2007

Cleared Mar 29, 2007

Cleared Mar 12, 2007

GRADIA DIRECT X

Cleared Feb 26, 2007

GC FUJI IX GP EXTRA

Cleared Jul 14, 2006

GC XLC-100 CAPSULE

Cleared Oct 20, 2005

Cleared Aug 22, 2005

Cleared Jul 07, 2005

NATURE-CRYL HI PLUS

Cleared Mar 04, 2005

FUSION PUTTY TYPE

Cleared Feb 03, 2005

Cleared Jan 27, 2005

Cleared Jan 25, 2005

GC TION GINGIVAL PROTECTOR

Cleared Nov 18, 2004

GRADIA DIRECT LOFLO

Cleared Oct 20, 2004

Cleared Jun 29, 2004

Cleared Jun 25, 2004

Cleared Apr 22, 2004

GC INITIAL MC, AL AND LF

Cleared Feb 02, 2004

Cleared Oct 20, 2003

Cleared Jan 30, 2003

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