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
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
1153341954342225K220369Esthetic ColorantEIH2022-09-23
1153341108374443K213147CERABIEN MiLaiEIH2022-03-28
1153341364206420K193060Noritake Super Porcelain EX-3EIH2020-01-30
1153341104924085K190436KATANA Zirconia BlockEIH2019-05-23
1153342057793278K170986KATANA Zirconia BlockEIH2017-07-13
1153341986251429K170834CERABIEN ZREIH2017-10-17
1153341745156246K153476KATANA AVENCIA BlockEBF2016-08-23
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
106011123191375K142623PANAVIA SA Cement Plus HandmixEMA2015-02-26
1153341901709363K133211ZIRTOUGHEIH2014-03-20
106011337720800K133078K-ETCHANT SYRINGE; NEEDLE TIP (E)KLE2013-12-20
106011761897125K132450CLEARFIL 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
106011309553142K131430CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIALKLE2013-08-30
106011849392677K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUIDEJK2013-08-27
106011916270209K130371CLEARFIL MAJESTY ES FLOWEBF2013-04-09
1153341285590444K121980ZIRPRIMEEIH2012-10-19
106011345401772K121583CLEARFIL 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
106011304787449K111980CLEARFIL TRI-S BOND PLUSKLE2011-10-14
106011583522757K111975CLEARFIL 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
106011685852374K092281CLEARFIL MAJESTY POSTERIOR PLTEBF2009-10-27
106011064970737K070325CLEARFIL MAJESTY ESTHETIC PLTEBF2007-03-21
106011177375342K063593CLEARFIL MAJESTY FLOWEBF2007-02-02
106011297916903K063228SURFACE COATEBD2006-12-08
106011035965937K062410CLEARFIL ESTHETIC CEMENT & DC BONDEMA2006-09-26
106011924418782K062409K-ETCHANT GELEBF2006-11-08
106011397097028K062382CLEARFIL DC BONDKLE2006-09-27
106011142880765K061906CLEARFIL CERAMIC PRIMEREBF2006-09-28
106012005543870K061860CLEARFIL 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
106011963540930K033938CLEARFIL PROTECT BONDKLE2004-01-29
1153341582457395K033049CZR PRESSEIH2003-10-24
106011195300634K032455PANAVIA F 2.0EMA2003-11-07
106011255444802K023002CLEARFIL AP-X PLTEBF2002-10-25
106011351323170K021427CLEARFIL SA PRIMERKLE2002-06-07
106011940992575K012742TEETHMATE F-1EBC2001-09-14
106011142948522K012740CLEARFIL AP-XEBF2001-09-14
106011082198200K012734CLEARFIL NEW BONDKLE2001-09-14
106011477741150K012733CARIES DETECTORLFC2001-09-14
106011991938866K012730CLEARFIL PORCELAIN BOND ACTIVATORKLE2001-09-13
106011371927885K012705CLEARFIL PHOTO COREEBF2001-09-11
106011439668403K012704CLEARFIL ST OPAQUEREBF2001-09-10
106011411690893K012703CLEARFIL CORE NEW BONDEBF2001-09-10
106011396472606K012442MODIFICATION TO CLEARFIL SE BONDKLE2001-09-10
106011663942389K012440MODIFICATION TO CLEARFIL LINER BOND 2VKLE2001-09-05
106011210396954K012438MODIFICATION TO PANAVIA 21EMA2001-09-05
106011675888767K012436MODIFICATION TO ALLOY PRIMERKLE2001-09-04
106011128902197K012432MODIFICATION TO CLEARFIL PHOTO BONDKLE2001-09-04
106011377001417
106011454180519
1153341563077593

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EIH212025-05-29
EBF172016-08-23
KLE152013-12-20
EMA72015-02-26
NHA12024-05-24
EJK12013-08-27
EBD12006-12-08
EBC12001-09-14
LFC12001-09-14

PMN#

121 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next