FDA.reportPublic FDA data

GC CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96123003002808289GC CORP.1N2026-01-0176-1 HASUNUMA-CHO ITABASHI-KU Tokyo JP 174-8585

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105171781956869K994077AROMA FINE (NORMAL AND FAST SET)ELW2000-01-27
105171789645005K993973FUJI II LC CAPSULEEBF2000-01-11
105171303215087K984505MIRACLE MIX POWDER/LIQUIDEMA1999-02-04
105171286663638K984365GC UNIFAST TRADEBI1999-02-25
105171997229749K981514GC FUJI BOND LCKLE1998-06-16
105171213256758K981461GC FUJI ORTHO LCDYH1998-06-25
105171127825682K981370MIRACLE MIX CAPSULEEMA1998-06-01
105171382721893K980695FUJI IEMA1998-04-13
105171656034756K980682FUJI IIEMA1998-04-03
105171278722287K972594METALPRIMER IIKLE1997-08-26
105171433867205K961584FUJI II LC (IMPROVED)EMA1996-05-24
105171194937158K961448FUJI IX GPEMA1996-07-08
105171024236619K961417GC FUJI ORTHODYH1996-05-24
105171713777381K955932EXAFLEX IMPRESSION MATERIAL (MODIFICATION)ELW1996-03-11
105171246884777K953166FUJI BOND LCKLE1995-09-27
105171089599276K951555FUJI IXEMA1995-05-23
105171690780030K950556FUJI ORTHO LCDYH1995-03-08
105171321255770K946100FUJI DUETEMA1995-01-20
105171637723563K942670GC PATTERN RESINEBG1994-10-18
105171432526864K935961GC FUJI COAT LCKLE1994-03-10
105171349986232K933206EXA BITE REGISTRATION MATERIALELW1993-09-29
105171946364945K913884FUJI II LCEMA1991-10-30
105171608812640K901999FUJI LINING CEMENT LIGHT CUREEJK1990-07-31
105171885875142K894282FIRST IMPRESSION TMELW1989-12-22
105171683055032K85146876 EMA LINING CEMENTEMA1985-05-01
105171453767878K812680G-C IMPRESSION SYRINGEEID1981-10-06
105171538961700K254109G-CEM UNIVERSALEMA2026-05-18
105171377337509K253317Cytrans™ ElashieldLYC2026-07-06
105171076252535K251946G aenial Universal Injectable IIEBF2025-08-29
105171704968944K250953EQUIA LC ONEEMA2025-09-19
105171173032387K200798G-CEM ONEEMA2020-11-24
105171211401862K193484GC Fuji Triage EPEMA2020-07-02
105171827597293K192597Cytrans GranulesLYC2020-08-17
105171641837953K192260everX FlowEBF2019-11-22
105171330170294K182854GC FujiCEM 2 (Improved)EMA2019-07-11
105171188774795K181011AIM2ELW2018-07-12
105172045613613K173500NMF004AEBF2018-03-08
105171505647314K172382GC Fuji DirectEMA2018-04-02
105171090759893K153325Gradia PlusEBF2016-07-12
105171222817109K153253GC Reline IIEBI2016-03-03
105171972034561K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerEMA2016-07-06
105171751355684K153136Initial LiSi PressEIH2016-06-30
105171856366608K153130Initial LiSi BlockEIH2016-09-13
105171023258461K133824CERASMARTEBF2014-03-14
105171990352940K123631MFP-051EBF2013-07-23
105171806894986K120243GAM-200EMA2012-06-27
105171481551434K113816GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SVNHA2013-01-30
105171107056042K111087FOUNDATIONLYC2011-11-29
105171484925757K110871FIT CHECKER ADVANCEDELW2011-06-17
105171249089107K102808MI VARNISHLBH2010-12-22
105171018930693K101420GC FUJI TEMPEMA2010-09-17
105171154332452K101346GC ORAL MOISTURIZING GELLFD2011-01-27
105171073736552K093749GC AADVA IMPLANT SYSTEMDZE2010-12-06
105171870320511K091388GCUC-505EBF2009-07-22
105171459733987K091106EQUIAEMA2009-06-17
105171207678164K082171GRADIA COREEBF2008-10-30
105171868762604K080724GC OPB-100DYH2008-06-11
105172040562927K073283GC GAM-100EMA2008-02-20
105171230500265K072425JNE IMPLANT SYSTEMDZE2008-03-10
105171442304222K072100GC AADVA ABUTMENTNHA2008-02-14
105171454544656K070840GVC-100EMA2007-05-15
105171738921086K061535GC XLC-100 CAPSULEEMA2006-07-14
105171861707903K052462G-COATEBD2005-10-20
105171416096015K051427GC FUJI FIL LCEMA2005-08-22
105171311408700K050059G-LIGHTEBZ2005-02-03
105171617386673K041471G-BONDKLE2004-06-29
105171923686745K032289FIT CHECKER IIELW2003-10-20
105171260899603K023814GRADIA DIRECTEBF2003-01-30
105171614981184K022430ISO FUNCTIONALELW2002-10-18
105171594574645K021038GC ELITE CEMENT 100EMA2002-05-03
105171727003587K020578GC FUJI ORTHO BAND PASTE PAKDYH2002-04-26
105171937249405K020342UNIFIL FLOWEBF2002-03-28
105172022794214K020117GC FUJI LINING LC PASTE PAKEMA2002-02-28
105171544857687K013997UNIFIL BONDKLE2002-02-20
105171479278936K013198FUJI VII CAPSULEEMA2001-10-29
105171025169334K003817PATTERN RESINEBG2001-01-16
105171923375593K001730GC FUJICEMEMA2000-07-17
105171713833449K001518GRADIAEBF2000-07-05
105171066176493
105171185799765
105171290781303
105171293360998
105171311643432
105171668654081
105171723204140
105172072797307

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EMA332026-05-18
EBF132025-08-29
ELW102018-07-12
KLE72004-06-29
DYH52008-06-11
EIH42016-09-13
NHA42013-01-30
DZE42010-12-06
LYC32026-07-06
EBG32001-01-16
EBI22016-03-03
LFD22011-01-27
LBH22010-12-22
EID21981-10-06
EBD12005-10-20
EBZ12005-02-03
EJK11990-07-31