FDA.reportPublic FDA data

SHOFU INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028081493002808149SHOFU INC.1N2026-01-0111 KAMITAKAMATSU-CHO FUKUINE, HIGASHIYAMA-KU Kyoto JP 605-0983

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
618821269804043K982461GLASIONOMER CEMENT CX PLUSEMA1998-08-24
618821029484490K973247VINTAGE HALOEIH1997-10-16
618821140217067K972292SOLIDEXEBF1997-10-29
618821175625206K962542AIR MOTOR HANDPIECE TN-102EFB1996-09-24
618821308460435K893481CRYSTAR(TM) ANTI-GREENING LIQUIDELL1989-07-14
618821848005143K884214CRYSTAR(TM) VINTAGE PORCELAINELL1988-12-08
618821007311185K861005GLASIONOMER BASE CEMENTEMA1986-04-25
618821806291969K850913GLAS IONOMER CEMENTEMA1985-04-10
618821858797543K841196HY-BOND ZINC OXIDE EUGENOL TEMP.EMA1984-05-11
618821527835646K834497SHOFU PORCELAIN STAINEIH1984-03-06
618821328764674K810765HY-BOND ZINC PHOSPHATE CEMENTEMA1981-06-12
618821855311681K810764HY-BOND POLYCARBOXYLATE CEMENTEMA1981-06-12
618821519518071K252808GlasIonomer FX-LCEMA2025-12-09
618821979662302K252165ZIRCONOMER PEMA2025-10-28
618821500589160K251470ResiCem EXEMA2025-07-11
618821925479514K233161BeautiLink SAEMA2023-09-28
618821843777856K222253GlasIonomer FX ULTRAEMA2022-09-22
618821757017190K213965BeautiBond XtremeKLE2022-03-18
618821236784499K212939Vintage Prime PressEIH2022-03-18
618821120783943K191794Vintage Art UniversalEIH2019-10-03
618822048235595K182869Fit SAEBF2019-01-09
618821757651970K181496VINTAGE PROEIH2018-12-18
618821363004539K180803BeautiBond UniversalKLE2018-09-26
618822005492428K180649BeautiCem Veneer KitEBF2018-06-11
618821181845870K172530BEAUTIFIL Flow Plus XEBF2017-12-06
618821758674293K172106SHOFU MZ Primer PlusKLE2017-08-31
618821347710973K163568SHOFU RESIN GLAZEEBD2017-08-16
618821438590340K162261CERAMAGE UPEBF2017-01-11
618821661447760K161891HC PrimerKLE2016-11-21
618821041506605K160596BEAUTIFIL II LSEBF2016-07-27
618821872039070K160203ADAMANT ZIRCONIA DISCEIH2016-10-19
618821311773134K160086SHOFU Enamel ConditionerEBF2016-07-21
618821594080006K152451VINTAGE Art LFEIH2015-12-11
618821393470796K152392VINTAGE LDEIH2016-01-08
618821283091077K151700BEAUTIFIL II GingivaEBF2016-03-02
618821527150979K151699BEAUTIFIL II EnamelEBF2015-12-10
618821043232647K132748BEAUTIFIL E POSTERIOR, BEAUTIFIL BULKEBF2013-12-04
618821718185380K132141BEAUTIFIL BULK FLOWABLEEBF2013-10-03
618821009711211K131504UNIVERSAL OPAQUEEBF2013-07-16
618821493835657K130841SHOFU BLOCK HCEBF2013-09-11
618822061189601K123119CERARESIN BONDKLE2012-11-28
618821070420407K122908PRG BARRIER COATLBH2013-04-26
618821973574998K122614VINTAGE MP PRESS OVEREIH2013-05-16
618821417818206K121749VERACIAELM2012-09-07
618821198600290K120159BEAUTICEM SAEMA2012-06-18
618821318540544K113426VERACIA SAELM2012-02-08
618821481241189K111855HY-BOND RESIGLASSEMA2011-11-17
618821928953525K111782BEAUTISEALANTEBC2011-09-16
618821940697324K111685IP TEMP CEMENTEMA2011-09-02
618821570008063K101621LITE ARTEBF2010-08-23
618821103268995K101603BEAUTIFIL FLOW PLUSEBF2010-08-23
618821496635455K093559VINTAGE MPEIH2010-03-03
618821730155440K082744BEAUTIBONDKLE2008-12-11
618821338648318K080834VINTAGE ARTEIH2008-06-11
618821589779316K080517RESICEMEMA2008-06-11
618821328154553K080068BEAUTIFIL OPAQUEREBF2008-02-28
618821811746170K071742BEAUTIFIL IIEBF2007-08-15
618821481750818K071452FL BOND IIKLE2007-07-09
618821198477496K052033VINTAGE ZREIH2005-11-18
618821063435657K051818BEAUTIFIL FLOWEBF2005-08-03
618821870140008K050401CERAMAGEEBF2005-04-28
618821526796148K040079M.L. PRIMERKLE2004-09-09
618821326397940K032416VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAINEIH2004-02-05
618821866352832K032165VINTAGE ALEIH2003-09-16
618821484900326K031467GLASIONOMER FX-IIEMA2003-07-17
618821880794634K010914BEAUTIFILEBF2001-04-20
618821090172992K002461HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENTEMA2000-09-26
618821058747773
618821173726960
618821425846719
618821454856553
618821538281537
618821623218183
618821710358420
618821841529119
618821855675542
618821861033662
618821963117301
618821966458371
618821982862802

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF202019-01-09
EMA172025-12-09
EIH142022-03-18
KLE82022-03-18
ELM22012-09-07
ELL21989-07-14
EBD12017-08-16
LBH12013-04-26
EBC12011-09-16
EFB11996-09-24