GC America, Inc. - FDA 510(k) Cleared Devices
125
Total
125
Cleared
0
Denied
125 devices
Cleared
Apr 13, 1998
FUJI I
Dental
49d
Cleared
Apr 03, 1998
FUJI II
Dental
39d
Cleared
Oct 21, 1997
HYDROFLEX
Dental
46d
Cleared
Aug 26, 1997
METALPRIMER II
Dental
46d
Cleared
Apr 08, 1997
HYDROFLEX
Dental
46d
Cleared
Oct 29, 1996
GC BASELINE
Dental
77d
Cleared
Jul 08, 1996
FUJI IX GP
Dental
83d
Cleared
May 24, 1996
GC FUJI ORTHO
Dental
42d
Cleared
May 24, 1996
FUJI II LC (IMPROVED)
Dental
30d
Cleared
Mar 11, 1996
EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
Dental
89d
Cleared
Sep 27, 1995
FUJI BOND LC
Dental
82d
Cleared
May 23, 1995
FUJI IX
Dental
49d
Cleared
Mar 08, 1995
FUJI ORTHO LC
Dental
29d
Cleared
Feb 07, 1995
THERMORESIN LC II
Dental
232d
Cleared
Jan 20, 1995
FUJI DUET
Dental
37d
Cleared
Oct 18, 1994
GC PATTERN RESIN
Dental
134d
Cleared
Sep 12, 1994
GC SURFLEX F
Dental
61d
Cleared
May 04, 1994
COE-SOFT LC
Dental
85d
Cleared
Mar 10, 1994
GC FUJI COAT LC
Dental
87d
Cleared
Mar 04, 1994
GC TEMPRON
Dental
81d
Cleared
Jan 26, 1994
KOOLINER II
Dental
84d
Cleared
Jan 21, 1994
REBARON LC
Dental
332d
Cleared
Jan 06, 1994
GC ELITE CEMENT
Dental
49d
Cleared
Sep 29, 1993
EXA BITE REGISTRATION MATERIAL
Dental
90d
Cleared
Jul 08, 1993
G-CERA ORBIT COLOUR COMMUNICATION SET
Dental
72d
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