FDA.reportPublic FDA data

KURARAY AMERICA, INC.

Matched from indexed company URL: KURARAY CO.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24382483002675355KURARAY AMERICA, INC.1Y2026-01-0132 Old Slip 7th FL NEW YORK NY US 10005
96147053009523116KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT1N2026-01-01300 HIGASHIYAMA MIYOSHI-CHO MIYOSHI Aichi JP 470-0293
30028074203002807420KURARAY NORITAKE DENTAL NIIGATA PLANT1N2026-01-012-28 KURASHIKI-CHO TAINAI Niigata JP 959-2653
96112593002807420KURARAY NORITAKE DENTAL KURASHIKI PLANT1N2020-04-251621 SAKAZU KURASHIKI Okayama JP 710-0801

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1153341218236778K992024SUPER PORCELAIN TI-22EIH1999-08-27
1153342060172841K992023GRAND CERAMEIH1999-09-03
1153341878758715K983470SUPER PORCELAIN STAIN- PURE WHITEEIH1998-12-22
1153341489974920K983247SUPER PORCELAIN ADDMATEEIH1998-11-03
1153341218911780K982766PASTE OPAQUE EX-3EIH1998-10-30
1153341577480090K884356NORITAKE SUPER PORCELAIN EX-3EIH1989-01-10
1153341578702905K250673CERABIEN MiLaiEIH2025-05-29
1153341489674896K233285KATANA Zirconia ONE For IMPLANTNHA2024-05-24
1468801717593589K231039CLEARFIL Universal Bond Quick 2KLE2023-12-13
1153341954342225K220369Esthetic ColorantEIH2022-09-23
1153341108374443K213147CERABIEN MiLaiEIH2022-03-28
1468801886200468K210504PANAVIA Veneer LCEMA2021-06-11
1153341364206420K193060Noritake Super Porcelain EX-3EIH2020-01-30
1468801964511030K191980CLEARFIL MAJESTY ES FlowEBF2019-11-18
1468801177250117K191133KATANA Cleaner, KATANA Cleaner (Trial)PME2019-10-08
1153341104924085K190436KATANA Zirconia BlockEIH2019-05-23
1468801627352378K183537PANAVIA SA Cement UniversalEMA2019-04-25
1468801230367748K182430CLEARFIL MAJESTY ICEBF2019-05-03
1153342057793278K170986KATANA Zirconia BlockEIH2017-07-13
1153341986251429K170834CERABIEN ZREIH2017-10-17
1468801815962298K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKLE2016-10-25
1468801551811462K153476KATANA AVENCIA BlockEBF2016-08-23
1153341745156246K153476KATANA AVENCIA BlockEBF2016-08-23
1468801744647804K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth PrimerEMA2015-08-21
1468801259826132K150703CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)KLE2015-08-13
1153341562161152K143439KATANA ZirconiaEIH2015-02-27
106011148371532K142625PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)EMA2015-01-27
1468801148371532K142625PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)EMA2015-01-27
106011123191375K142623PANAVIA SA Cement Plus HandmixEMA2015-02-26
1468801123191375K142623PANAVIA SA Cement Plus HandmixEMA2015-02-26
1153341901709363K133211ZIRTOUGHEIH2014-03-20
106011337720800K133078K-ETCHANT SYRINGE; NEEDLE TIP (E)KLE2013-12-20
1468801337720800K133078K-ETCHANT SYRINGE; NEEDLE TIP (E)KLE2013-12-20
106011761897125K132450CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BONDKLE2013-11-01
1468801761897125K132450CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BONDKLE2013-11-01
106011264679274K131432CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFILKLE2013-08-22
1468801264679274K131432CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFILKLE2013-08-22
106011309553142K131430CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIALKLE2013-08-30
1468801309553142K131430CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIALKLE2013-08-30
106011849392677K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUIDEJK2013-08-27
1468801849392677K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUIDEJK2013-08-27
106011916270209K130371CLEARFIL MAJESTY ES FLOWEBF2013-04-09
1468801916270209K130371CLEARFIL MAJESTY ES FLOWEBF2013-04-09
1153341285590444K121980ZIRPRIMEEIH2012-10-19
106011345401772K121583CLEARFIL MAJESTY FLOWEBF2012-07-25
1468801345401772K121583CLEARFIL MAJESTY FLOWEBF2012-07-25
106011215655823K120379PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA SEMA2012-03-30
106011557852344K120378PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA SEMA2012-03-30
106011376980761K111982CLEARFIL DC CORE PLUSEBF2011-11-17
1468801376980761K111982CLEARFIL DC CORE PLUSEBF2011-11-17
106011304787449K111980CLEARFIL TRI-S BOND PLUSKLE2011-10-14
1468801304787449K111980CLEARFIL TRI-S BOND PLUSKLE2011-10-14
106011583522757K111975CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACKKLE2011-10-14
1468801583522757K111975CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACKKLE2011-10-14
1153342050766479K111107SUPER PORCELAIN EX-3 UNIVERSAL OPAQUEEIH2011-06-30
106011946942033K100328CLEARFIL MAJETY POSTERIOREBF2010-03-05
1468801946942033K100328CLEARFIL MAJETY POSTERIOREBF2010-03-05
106011685852374K092281CLEARFIL MAJESTY POSTERIOR PLTEBF2009-10-27
1468801685852374K092281CLEARFIL MAJESTY POSTERIOR PLTEBF2009-10-27
106011064970737K070325CLEARFIL MAJESTY ESTHETIC PLTEBF2007-03-21
1468801064970737K070325CLEARFIL MAJESTY ESTHETIC PLTEBF2007-03-21
106011177375342K063593CLEARFIL MAJESTY FLOWEBF2007-02-02
1468801177375342K063593CLEARFIL MAJESTY FLOWEBF2007-02-02
106011297916903K063228SURFACE COATEBD2006-12-08
1468801297916903K063228SURFACE COATEBD2006-12-08
106011035965937K062410CLEARFIL ESTHETIC CEMENT & DC BONDEMA2006-09-26
106011924418782K062409K-ETCHANT GELEBF2006-11-08
1468801924418782K062409K-ETCHANT GELEBF2006-11-08
106011397097028K062382CLEARFIL DC BONDKLE2006-09-27
1468801397097028K062382CLEARFIL DC BONDKLE2006-09-27
106011142880765K061906CLEARFIL CERAMIC PRIMEREBF2006-09-28
1468801142880765K061906CLEARFIL CERAMIC PRIMEREBF2006-09-28
106012005543870K061860CLEARFIL MAJESTY ESTHETICEBF2006-09-18
1468802005543870K061860CLEARFIL MAJESTY ESTHETICEBF2006-09-18
1153341207500061K052304SUPER PORCELAIN EX-3 PRESSEIH2005-11-23
1153341072378442K050920CZR PRESS LF STAINSEIH2005-05-11
1153341395090046K043462CZR PRESS LFEIH2005-01-11
106011763828887K033970CLEARFIL PHOTO CORE PLTEBF2004-03-26
1468801763828887K033970CLEARFIL PHOTO CORE PLTEBF2004-03-26
106011963540930K033938CLEARFIL PROTECT BONDKLE2004-01-29
1468801963540930K033938CLEARFIL PROTECT BONDKLE2004-01-29
1153341582457395K033049CZR PRESSEIH2003-10-24
106011195300634K032455PANAVIA F 2.0EMA2003-11-07
1468801195300634K032455PANAVIA F 2.0EMA2003-11-07
106011255444802K023002CLEARFIL AP-X PLTEBF2002-10-25
1468801255444802K023002CLEARFIL AP-X PLTEBF2002-10-25
106011351323170K021427CLEARFIL SA PRIMERKLE2002-06-07
1468801351323170K021427CLEARFIL SA PRIMERKLE2002-06-07
106011940992575K012742TEETHMATE F-1EBC2001-09-14
1468801940992575K012742TEETHMATE F-1EBC2001-09-14
106011142948522K012740CLEARFIL AP-XEBF2001-09-14
1468801142948522K012740CLEARFIL AP-XEBF2001-09-14
106011082198200K012734CLEARFIL NEW BONDKLE2001-09-14
1468801082198200K012734CLEARFIL NEW BONDKLE2001-09-14
106011477741150K012733CARIES DETECTORLFC2001-09-14
1468801477741150K012733CARIES DETECTORLFC2001-09-14
106011991938866K012730CLEARFIL PORCELAIN BOND ACTIVATORKLE2001-09-13
1468801991938866K012730CLEARFIL PORCELAIN BOND ACTIVATORKLE2001-09-13
106011371927885K012705CLEARFIL PHOTO COREEBF2001-09-11
1468801371927885K012705CLEARFIL PHOTO COREEBF2001-09-11
106011439668403K012704CLEARFIL ST OPAQUEREBF2001-09-10
1468801439668403K012704CLEARFIL ST OPAQUEREBF2001-09-10
106011411690893K012703CLEARFIL CORE NEW BONDEBF2001-09-10
1468801411690893K012703CLEARFIL CORE NEW BONDEBF2001-09-10
106011396472606K012442MODIFICATION TO CLEARFIL SE BONDKLE2001-09-10
1468801396472606K012442MODIFICATION TO CLEARFIL SE BONDKLE2001-09-10
106011663942389K012440MODIFICATION TO CLEARFIL LINER BOND 2VKLE2001-09-05
1468801663942389K012440MODIFICATION TO CLEARFIL LINER BOND 2VKLE2001-09-05
106011210396954K012438MODIFICATION TO PANAVIA 21EMA2001-09-05
1468801210396954K012438MODIFICATION TO PANAVIA 21EMA2001-09-05
106011675888767K012436MODIFICATION TO ALLOY PRIMERKLE2001-09-04
1468801675888767K012436MODIFICATION TO ALLOY PRIMERKLE2001-09-04
106011128902197K012432MODIFICATION TO CLEARFIL PHOTO BONDKLE2001-09-04
1468801128902197K012432MODIFICATION TO CLEARFIL PHOTO BONDKLE2001-09-04
106011377001417
106011454180519
1468801124713534
1468801377001417
1153341563077593

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF362019-11-18
KLE332023-12-13
EIH212025-05-29
EMA142021-06-11
EJK22013-08-27
EBD22006-12-08
EBC22001-09-14
LFC22001-09-14
NHA12024-05-24
PME12019-10-08

PMN#

ZIRTOUGH

2014-03-20

KURARAY NORITAKE DENTAL INC.

ZIRPRIME

2012-10-19

KURARAY NORITAKE DENTAL INC.

121 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next