GC CORPORATION-FUJI OYAMA FACTORY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028070503002807050GC CORPORATION-FUJI OYAMA FACTORY1N2026-01-01584-1 NAKAHINATA OYAMA-CHO SUNTO-GUN, Shizuoka-Ken JP 410-1307

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105161781956869K994077AROMA FINE (NORMAL AND FAST SET)ELW2000-01-27
105161789645005K993973FUJI II LC CAPSULEEBF2000-01-11
105161303215087K984505MIRACLE MIX POWDER/LIQUIDEMA1999-02-04
105161997229749K981514GC FUJI BOND LCKLE1998-06-16
105161213256758K981461GC FUJI ORTHO LCDYH1998-06-25
105161127825682K981370MIRACLE MIX CAPSULEEMA1998-06-01
105161382721893K980695FUJI IEMA1998-04-13
105161656034756K980682FUJI IIEMA1998-04-03
105161433867205K961584FUJI II LC (IMPROVED)EMA1996-05-24
105161194937158K961448FUJI IX GPEMA1996-07-08
105161024236619K961417GC FUJI ORTHODYH1996-05-24
105161713777381K955932EXAFLEX IMPRESSION MATERIAL (MODIFICATION)ELW1996-03-11
105161246884777K953166FUJI BOND LCKLE1995-09-27
105161089599276K951555FUJI IXEMA1995-05-23
105161690780030K950556FUJI ORTHO LCDYH1995-03-08
105161321255770K946100FUJI DUETEMA1995-01-20
105161432526864K935961GC FUJI COAT LCKLE1994-03-10
105161349986232K933206EXA BITE REGISTRATION MATERIALELW1993-09-29
105161946364945K913884FUJI II LCEMA1991-10-30
105161608812640K901999FUJI LINING CEMENT LIGHT CUREEJK1990-07-31
105161393052506K880848FUJI CAP II CAPSULE & APPLIEREMA1988-05-16
105161501003575K85146976 ELW BITE CHECKER SILICONEELW1985-05-01
105161683055032K85146876 EMA LINING CEMENTEMA1985-05-01
105161235474806K842994EMA FREEGENOL DENTAL CEMENTEMA1984-10-18
105161188774795K181011AIM2ELW2018-07-12
105161505647314K172382GC Fuji DirectEMA2018-04-02
105161222817109K153253GC Reline IIEBI2016-03-03
105161751355684K153136Initial LiSi PressEIH2016-06-30
105161856366608K153130Initial LiSi BlockEIH2016-09-13
105161249089107K102808MI VARNISHLBH2010-12-22
105161018930693K101420GC FUJI TEMPEMA2010-09-17
105161459733987K091106EQUIAEMA2009-06-17
105161868762604K080724GC OPB-100DYH2008-06-11
105161159366086K073588GC MODELS OPA-100 AND JC-50DYH2008-02-15
105162040562927K073283GC GAM-100EMA2008-02-20
105161230500265K072425JNE IMPLANT SYSTEMDZE2008-03-10
105161454544656K070840GVC-100EMA2007-05-15
105161266453867K070319GC FUJI IX GP EXTRAEMA2007-02-26
105161738921086K061535GC XLC-100 CAPSULEEMA2006-07-14
105161861707903K052462G-COATEBD2005-10-20
105161416096015K051427GC FUJI FIL LCEMA2005-08-22
105161311408700K050059G-LIGHTEBZ2005-02-03
105161160661228K042348GRADIA DIRECT LOFLOEBF2004-11-18
105161617386673K041471G-BONDKLE2004-06-29
105161727003587K020578GC FUJI ORTHO BAND PASTE PAKDYH2002-04-26
105161937249405K020342UNIFIL FLOWEBF2002-03-28
105162022794214K020117GC FUJI LINING LC PASTE PAKEMA2002-02-28
105161479278936K013198FUJI VII CAPSULEEMA2001-10-29
105161923375593K001730GC FUJICEMEMA2000-07-17
105161296442718

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EMA442018-04-02
DYH112008-06-11
ELW82018-07-12
KLE82004-06-29
EBF62004-11-18
EIH42016-09-13
EBI22016-03-03
EBD22005-10-20
EBZ22005-02-03
EJK21990-07-31
LBH12010-12-22
DZE12008-03-10