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
26-50 of 125
Cleared Mar 14, 2014
CERASMART
K133824 · EBF
Dental · 87d
Cleared Mar 06, 2014
OPTIGLAZE COLOR
K133836 · EBD
Dental · 78d
Cleared Jul 23, 2013
MFP-051
K123631 · EBF
Dental · 242d
Cleared Jan 30, 2013
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
K113816 · NHA
Dental · 400d
Cleared Jun 27, 2012
GAM-200
K120243 · EMA
Dental · 152d
Cleared May 10, 2012
GC BLUE SILICONE
K120521 · ELW
Dental · 79d
Cleared Jun 30, 2011
GC AADVA BO AC ABUTMENTS
K103234 · NHA
Dental · 240d
Cleared Jun 17, 2011
FIT CHECKER ADVANCED
K110871 · ELW
Dental · 80d
Cleared Jan 27, 2011
GC ORAL MOISTURIZING GEL
K101346 · LFD
Dental · 259d
Cleared Dec 22, 2010
MI VARNISH
K102808 · LBH
Dental · 85d
Cleared Dec 06, 2010
GC AADVA IMPLANT SYSTEM
K093749 · DZE
Dental · 364d
Cleared Sep 17, 2010
GC FUJI TEMP
K101420 · EMA
Dental · 120d
Cleared Sep 29, 2009
AADVA ZR COLORING LIQUID
K092020 · EIH
Dental · 85d
Cleared Jul 22, 2009
GCUC-505
K091388 · EBF
Dental · 72d
Cleared Jun 17, 2009
EQUIA
K091106 · EMA
Dental · 62d
Cleared Jun 10, 2009
MI FLOW (GCUC-450)
K090747 · EBF
Dental · 82d
Cleared Nov 26, 2008
GC AADVA ZR DISK
K082740 · EIH
Dental · 69d
Cleared Nov 14, 2008
GDLS-200
K082434 · EBF
Dental · 81d
Cleared Oct 30, 2008
GRADIA CORE
K082171 · EBF
Dental · 90d
Cleared Oct 21, 2008
G-BOND PLUS
K082768 · KLE
Dental · 29d
Cleared Jun 11, 2008
GC OPB-100
K080724 · DYH
Dental · 89d
Cleared Jun 05, 2008
GRADIA FORTE
K080478 · EBF
Dental · 104d
Cleared Apr 11, 2008
UNIFAST III
K073106 · EBG
Dental · 161d
Cleared Mar 10, 2008
JNE IMPLANT SYSTEM
K072425 · DZE
Dental · 194d
Cleared Feb 20, 2008
GC GAM-100
K073283 · EMA
Dental · 91d

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