Manufacturer registered with FDA
Kuraray Noritake Dental, Inc.
KURASHIKI, Japan. Lists 12 dental device types with FDA across 2 registered establishments, and holds 32 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 101
- 510(k) clearances
- 322012–2025
- Markets registered in
- 12581 registrations outside the US
- Establishments
- 2Japan
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Kuraray Noritake Dental, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: JapanOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Kuraray Noritake Dental, Inc. | 32 clearances | 2012–2025 | Below |
| Canada | Health Canada | Registration holder | KURARAY NORITAKE DENTAL INC. | 450 | 1999–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KURARAY NORITAKE DENTAL INC.KURARAY NORITAKE DENTAL INC · Kuraray Noritake Dental Inc. | 50 | 2002–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kuraray Noritake Dental Inc. | 37 | 1998–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Kuraray Noritake Dental Inc | 12 | 2007–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | KURARAY NORITAKE DENTAL INC.Kuraray Noritake Dental Inc | 11 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Kuraray Noritake Dental Inc. | 9 | 2024–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | KURARAY NORITAKE DENTAL INC. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 可乐丽则武齿科株式会社KURARAY NORITAKE DENTAL INC.可乐丽则武齿科株式会社KURARAY NORITAKE DENTAL INC.（原文：クラレノリタケデンタル株式会社 ） · 可乐丽则武齿科株式会社Kuraray Noritake Dental Inc. (クラレノリタケデンタル株式会社) | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Kuraray Noritake Dental Inc. | 3 | 2020–2023 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Kuraray Noritake Dental Inc | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Kuraray Noritake Dental Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Kuraray Noritake Dental, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | CERABIENCERABIEN MiLaiCERABIEN ZRCERABIEN ZR SS BASIC FULL KITCERABIEN ZR SS ESTHETIC WHITE KITCERABIEN ZR TRIAL KIT SS A2CERABIEN ZR TRIAL KIT SS NV1120CERABIEN ZR VALUE SHADE FULL KITCZR PRESSCZR PRESS Esthetic White Kit 28 moreCZR PRESS LFCZR PRESS LF ESTHETIC WHITE LAYERING KITCZR PRESS Trial-H KitCZR PRESS Trial-L KitEsthetic ColorantEX-3 PRESSEX-3 PRESS LFEX-3 PRESS LF ESTHETIC WHITE KITEX-3 PRESS LF ESTHETIC WHITE LAYERING KITEX-3 PRESS TRIAL KIT H1EX-3 PRESS TRIAL KIT H2EX-3 PRESS TRIAL KIT L1EX-3 PRESS TRIAL KIT L2KATANA ZirconiaKATANA Zirconia BlockKATANA Zirconia ONENoritake Super Porcelain EX-3Noritake Super Porcelain EX-3 ESTHETIC WHITE KITNoritake Super Porcelain EX-3 FULL KIT PSTNoritake Super Porcelain EX-3 n COLOR FULL KIT PSTNoritake Super Porcelain EX-3 n COLOR INTRO KITNoritake Super Porcelain EX-3 n COLOR INTRO POBA KITNoritake Super Porcelain EX-3 NORITAKE ORIGINAL SHADE KITNoritake Super Porcelain EX-3 TRIAL KIT NV1120Noritake Super Porcelain EX-3 TRIAL KIT UP nA2Noritake Super Porcelain EX-3 Value Shade FULL KITNoritake Super Porcelain Ti-22SCREENING PORCELAIN | 2010 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | ALLOY PRIMERCLEARFIL CERAMIC PRIMER PLUSCLEARFIL DC ActivatorCLEARFIL LINER BOND 2VCLEARFIL PHOTO BONDCLEARFIL PORCELAIN BOND ACTIVATORCLEARFIL SA PRIMERCLEARFIL SE BONDCLEARFIL SE BOND 2CLEARFIL SE BOND Restorative Kit 8 moreCLEARFIL SE ProtectCLEARFIL TRI-S BOND PLUSCLEARFIL Universal BondCLEARFIL Universal Bond KitCLEARFIL Universal Bond QuickCLEARFIL Universal Bond Quick 2K-ETCHANT SyringePANAVIA SA Cement Universal | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | CLEARFIL AP-XCLEARFIL AP-X PLTCLEARFIL DC CORE PLUSCLEARFIL MAJESTY ES FlowCLEARFIL MAJESTY ES Flow UniversalCLEARFIL MAJESTY ES-2CLEARFIL MAJESTY FlowCLEARFIL MAJESTY ICCLEARFIL MAJESTY IC BulkCLEARFIL MAJESTY IC Trial Kit 7 moreCLEARFIL MAJESTY PosteriorCLEARFIL MAJESTY Posterior PLTCLEARFIL PHOTO CORECLEARFIL PHOTO CORE PLTCLEARFIL SE BOND 2CLEARFIL ST OPAQUERK-ETCHANT GEL | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Maker | CLEARFIL SE BOND 2PANAVIA 21PANAVIA F 2PANAVIA F 2 Complete KitPANAVIA SA Cement UniversalPANAVIA V5PANAVIA Veneer LC | 2008 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | CLEARFIL SE ProtectCLEARFIL Universal BondCLEARFIL Universal Bond KitKATANA Cleaner | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | CLEARFIL DC CORE PLUS Guide tip (L)CLEARFIL DC CORE PLUS Guide tip (S)CLEARFIL DC CORE PLUS Mixing tipPANAVIA SA Cement Universal Automix Endo tip (SS)PANAVIA SA Cement Universal Automix Mixing tipPANAVIA V5 Endo tip (S)PANAVIA V5 Mixing tip | 2009 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | TEETHMATE DESENSITIZER | 2013 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | NORITAKE DENTAL SUPPLY CO. LTD | 2010 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Applicator brush (endo<black>)Applicator brush (fine<silver>)Applicator brush (superfine<white>)Disposable brush tips (black)Disposable brush tips (white) | 2024 |
| Caries Detection DeviceLFC · Class 2 | Caries detection devices | Maker | CARIES DETECTOR | 2008 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | KATANA Zirconia ONE For IMPLANT | 2024 |
| External Cleaning SolutionPME · Class 2 | — | Maker | KATANA Cleaner | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Kuraray Noritake Dental, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 May 2025 | K250673 | CERABIEN MiLai | EIH Porcelain Powder |
| 24 May 2024 | K233285 | KATANA Zirconia ONE For IMPLANT | NHA Endosseous Dental Implant Abutment |
| 13 Dec 2023 | K231039 | CLEARFIL Universal Bond Quick 2 | KLE Resin Tooth Bonding Agent |
| 23 Sep 2022 | K220369 | Esthetic Colorant | EIH Porcelain Powder |
| 28 Mar 2022 | K213147 | CERABIEN MiLai | EIH Porcelain Powder |
| 11 Jun 2021 | K210504 | PANAVIA Veneer LC | EMA Dental Cement |
| 30 Jan 2020 | K193060 | Noritake Super Porcelain EX-3 | EIH Porcelain Powder |
| 18 Nov 2019 | K191980 | CLEARFIL MAJESTY ES Flow | EBF Resin Tooth Shade Material |
| 8 Oct 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | PME External Cleaning Solution |
| 23 May 2019 | K190436 | KATANA Zirconia Block | EIH Porcelain Powder |
| 3 May 2019 | K182430 | CLEARFIL MAJESTY IC | EBF Resin Tooth Shade Material |
| 25 Apr 2019 | K183537 | PANAVIA SA Cement Universal | EMA Dental Cement |
| 17 Oct 2017 | K170834 | CERABIEN ZR | EIH Porcelain Powder |
| 13 Jul 2017 | K170986 | KATANA Zirconia Block | EIH Porcelain Powder |
| 25 Oct 2016 | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | KLE Resin Tooth Bonding Agent |
| 23 Aug 2016 | K153476 | KATANA AVENCIA Block | EBF Resin Tooth Shade Material |
| 21 Aug 2015 | K150704 | PANAVIA 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 Primer | EMA Dental Cement |
| 13 Aug 2015 | K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | KLE Resin Tooth Bonding Agent |
| 27 Feb 2015 | K143439 | KATANA Zirconia | EIH Porcelain Powder |
| 26 Feb 2015 | K142623 | PANAVIA SA Cement Plus Handmix | EMA Dental Cement |
| 27 Jan 2015 | K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) | EMA Dental Cement |
| 20 Mar 2014 | K133211 | ZIRTOUGH | EIH Porcelain Powder |
| 20 Dec 2013 | K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | KLE Resin Tooth Bonding Agent |
| 1 Nov 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | KLE Resin Tooth Bonding Agent |
| 11 Oct 2013 | K131534 | KATANA ZIRCONIA | EIH Porcelain Powder |
| 30 Aug 2013 | K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | KLE Resin Tooth Bonding Agent |
| 27 Aug 2013 | K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | EJK Calcium Hydroxide Cavity Liner |
| 22 Aug 2013 | K131432 | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL | KLE Resin Tooth Bonding Agent |
| 9 Apr 2013 | K130371 | CLEARFIL MAJESTY ES FLOW | EBF Resin Tooth Shade Material |
| 11 Dec 2012 | K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | EJK Calcium Hydroxide Cavity Liner |
| 19 Oct 2012 | K121980 | ZIRPRIME | EIH Porcelain Powder |
| 25 Jul 2012 | K121583 | CLEARFIL MAJESTY FLOW | EBF Resin Tooth Shade Material |
Also lists devices cleared under other names
Kuraray Noritake Dental, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Kuraray Medical, Inc. (18), Noritake Co., Inc. (11), Kuraray America, Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Nov 2011 | K111982 | CLEARFIL DC CORE PLUS | Kuraray America, Inc. | EBF Resin Tooth Shade Material |
| 14 Oct 2011 | K111980 | CLEARFIL TRI-S BOND PLUS | Kuraray America, Inc. | KLE Resin Tooth Bonding Agent |
| 30 Jun 2011 | K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE | Noritake Co., Inc. | EIH Porcelain Powder |
| 5 Mar 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 27 Oct 2009 | K092281 | CLEARFIL MAJESTY POSTERIOR PLT | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 2 Feb 2007 | K063593 | CLEARFIL MAJESTY FLOW | Kuraray America, Inc. | EBF Resin Tooth Shade Material |
| 8 Nov 2006 | K062409 | K-ETCHANT GEL | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 23 Nov 2005 | K052304 | SUPER PORCELAIN EX-3 PRESS | Noritake Co., Inc. | EIH Porcelain Powder |
| 11 May 2005 | K050920 | CZR PRESS LF STAINS | Noritake Co., Inc. | EIH Porcelain Powder |
| 11 Jan 2005 | K043462 | CZR PRESS LF | Noritake Co., Inc. | EIH Porcelain Powder |
| 26 Mar 2004 | K033970 | CLEARFIL PHOTO CORE PLT | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 29 Jan 2004 | K033938 | CLEARFIL PROTECT BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 7 Nov 2003 | K032455 | PANAVIA F 2.0 | Kuraray Medical, Inc. | EMA Dental Cement |
| 24 Oct 2003 | K033049 | CZR PRESS | Noritake Co., Inc. | EIH Porcelain Powder |
| 25 Oct 2002 | K023002 | CLEARFIL AP-X PLT | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 7 Jun 2002 | K021427 | CLEARFIL SA PRIMER | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 14 Sep 2001 | K012733 | CARIES DETECTOR | Kuraray Medical, Inc. | LFC Caries Detection Device |
| 14 Sep 2001 | K012740 | CLEARFIL AP-X | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 13 Sep 2001 | K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 11 Sep 2001 | K012705 | CLEARFIL PHOTO CORE | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 10 Sep 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 10 Sep 2001 | K012704 | CLEARFIL ST OPAQUER | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 5 Sep 2001 | K012438 | MODIFICATION TO PANAVIA 21 | Kuraray Medical, Inc. | EMA Dental Cement |
| 5 Sep 2001 | K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 4 Sep 2001 | K012436 | MODIFICATION TO ALLOY PRIMER | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 4 Sep 2001 | K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 3 Sep 1999 | K992023 | GRAND CERAM | Noritake Co., Inc. | EIH Porcelain Powder |
| 27 Aug 1999 | K992024 | SUPER PORCELAIN TI-22 | Noritake Co., Inc. | EIH Porcelain Powder |
| 22 Dec 1998 | K983470 | SUPER PORCELAIN STAIN- PURE WHITE | Noritake Co., Inc. | EIH Porcelain Powder |
| 3 Nov 1998 | K983247 | SUPER PORCELAIN ADDMATE | Noritake Co., Inc. | EIH Porcelain Powder |
| 30 Oct 1998 | K982766 | PASTE OPAQUE EX-3 | Noritake Co., Inc. | EIH Porcelain Powder |
| 10 Jan 1989 | K884356 | NORITAKE SUPER PORCELAIN EX-3 | Noritake Co., Inc. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KURARAY NORITAKE DENTAL INC. MIYOSHI PLANTFDA reg. 9614705 | MIYOSHI Aichi, Japan | Manufacturer |
| KURARAY NORITAKE DENTAL NIIGATA PLANTFDA reg. 3002807420 | TAINAI Niigata, Japan | Manufacturer |
Other names on FDA records
Kuraray Noritake Dental Niigata Plant · Kuraray Noritake Dental Inc. Miyoshi Plant
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030414, 10031961). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.