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
101-125 of 125
Cleared Apr 13, 1998
FUJI I
K980695 · EMA
Dental · 49d
Cleared Apr 03, 1998
FUJI II
K980682 · EMA
Dental · 39d
Cleared Oct 21, 1997
HYDROFLEX
K973343 · ELW
Dental · 46d
Cleared Aug 26, 1997
METALPRIMER II
K972594 · KLE
Dental · 46d
Cleared Apr 08, 1997
HYDROFLEX
K970656 · ELW
Dental · 46d
Cleared Oct 29, 1996
GC BASELINE
K963144 · EBI
Dental · 77d
Cleared Jul 08, 1996
FUJI IX GP
K961448 · EMA
Dental · 83d
Cleared May 24, 1996
GC FUJI ORTHO
K961417 · DYH
Dental · 42d
Cleared May 24, 1996
FUJI II LC (IMPROVED)
K961584 · EMA
Dental · 30d
Cleared Mar 11, 1996
EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
K955932 · ELW
Dental · 89d
Cleared Sep 27, 1995
FUJI BOND LC
K953166 · KLE
Dental · 82d
Cleared May 23, 1995
FUJI IX
K951555 · EMA
Dental · 49d
Cleared Mar 08, 1995
FUJI ORTHO LC
K950556 · DYH
Dental · 29d
Cleared Feb 07, 1995
THERMORESIN LC II
K942993 · EBF
Dental · 232d
Cleared Jan 20, 1995
FUJI DUET
K946100 · EMA
Dental · 37d
Cleared Oct 18, 1994
GC PATTERN RESIN
K942670 · EBG
Dental · 134d
Cleared Sep 12, 1994
GC SURFLEX F
K943388 · ELW
Dental · 61d
Cleared May 04, 1994
COE-SOFT LC
K940565 · EBI
Dental · 85d
Cleared Mar 10, 1994
GC FUJI COAT LC
K935961 · KLE
Dental · 87d
Cleared Mar 04, 1994
GC TEMPRON
K935960 · EBG
Dental · 81d
Cleared Jan 26, 1994
KOOLINER II
K935261 · EBI
Dental · 84d
Cleared Jan 21, 1994
REBARON LC
K930939 · EBI
Dental · 332d
Cleared Jan 06, 1994
GC ELITE CEMENT
K935521 · EMA
Dental · 49d
Cleared Sep 29, 1993
EXA BITE REGISTRATION MATERIAL
K933206 · ELW
Dental · 90d
Cleared Jul 08, 1993
G-CERA ORBIT COLOUR COMMUNICATION SET
K932039 · EIH
Dental · 72d

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