Not currently registered with FDA under this name
Kuraray Medical, Inc.
Chiyoda-Ku, Japan. Named as applicant on 42 dental 510(k) clearances between 2001 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 422001–2012
- Markets registered in
- 312 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Kuraray Medical, 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 | Applicant | Kuraray Medical, Inc. | 42 clearances | 2001–2012 | Below |
| Taiwan | TFDA | Manufacturer | KURARAY MEDICAL INC. | 10 | 1981–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kuraray Medical IncKuraray Medical Inc. | 2 | 1999–2003 | 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
510(k) clearances
Clearances on which FDA names Kuraray Medical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Mar 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA Dental Cement |
| 30 Mar 2012 | K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA Dental Cement |
| 14 Oct 2011 | K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | KLE Resin Tooth Bonding Agent |
| 5 Mar 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | EBF Resin Tooth Shade Material |
| 27 Oct 2009 | K092281 | CLEARFIL MAJESTY POSTERIOR PLT | EBF Resin Tooth Shade Material |
| 28 Jul 2008 | K081583 | CLEARFIL SA CEMENT | EMA Dental Cement |
| 20 Jun 2007 | K071169 | CLEARFIL MAJESTY POSTERIOR PLT | EBF Resin Tooth Shade Material |
| 21 Mar 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT | EBF Resin Tooth Shade Material |
| 8 Nov 2006 | K062409 | K-ETCHANT GEL | EBF Resin Tooth Shade Material |
| 28 Sep 2006 | K061906 | CLEARFIL CERAMIC PRIMER | EBF Resin Tooth Shade Material |
| 27 Sep 2006 | K062382 | CLEARFIL DC BOND | KLE Resin Tooth Bonding Agent |
| 26 Sep 2006 | K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND | EMA Dental Cement |
| 18 Sep 2006 | K061860 | CLEARFIL MAJESTY ESTHETIC | EBF Resin Tooth Shade Material |
| 17 Dec 2004 | K043177 | CLEAFIL DC CORE AUTOMIX | EBF Resin Tooth Shade Material |
| 26 Nov 2004 | K042913 | CLEARFIL TRI-S BOND | KLE Resin Tooth Bonding Agent |
| 26 Mar 2004 | K033970 | CLEARFIL PHOTO CORE PLT | EBF Resin Tooth Shade Material |
| 29 Jan 2004 | K033938 | CLEARFIL PROTECT BOND | KLE Resin Tooth Bonding Agent |
| 22 Dec 2003 | K033267 | EPRICORD | EBF Resin Tooth Shade Material |
| 7 Nov 2003 | K032455 | PANAVIA F 2.0 | EMA Dental Cement |
| 26 Mar 2003 | K024356 | CLEARFIL SILANE KIT | KLE Resin Tooth Bonding Agent |
| 11 Feb 2003 | K023842 | CLEARFIL SE BOND PLUS | KLE Resin Tooth Bonding Agent |
| 25 Oct 2002 | K023002 | CLEARFIL AP-X PLT | EBF Resin Tooth Shade Material |
| 24 Oct 2002 | K022999 | CLEARFIL AP-X PLT INTRO KIT | EBF Resin Tooth Shade Material |
| 7 Jun 2002 | K021427 | CLEARFIL SA PRIMER | KLE Resin Tooth Bonding Agent |
| 14 Sep 2001 | K012742 | TEETHMATE F-1 | EBC Pit and Fissure Sealant and Conditioner |
| 14 Sep 2001 | K012740 | CLEARFIL AP-X | EBF Resin Tooth Shade Material |
| 14 Sep 2001 | K012737 | CHROMA ZONE COLOR STAIN | EBF Resin Tooth Shade Material |
| 14 Sep 2001 | K012735 | CLEARFIL DC CEMENT | EMA Dental Cement |
| 14 Sep 2001 | K012734 | CLEARFIL NEW BOND | KLE Resin Tooth Bonding Agent |
| 14 Sep 2001 | K012733 | CARIES DETECTOR | LFC Caries Detection Device |
| 13 Sep 2001 | K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR | KLE Resin Tooth Bonding Agent |
| 13 Sep 2001 | K012729 | CLEARFIL REPAIR | KLE Resin Tooth Bonding Agent |
| 13 Sep 2001 | K012707 | ESTENIA | EBF Resin Tooth Shade Material |
| 11 Sep 2001 | K012705 | CLEARFIL PHOTO CORE | EBF Resin Tooth Shade Material |
| 10 Sep 2001 | K012704 | CLEARFIL ST OPAQUER | EBF Resin Tooth Shade Material |
| 10 Sep 2001 | K012703 | CLEARFIL CORE NEW BOND | EBF Resin Tooth Shade Material |
| 10 Sep 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | KLE Resin Tooth Bonding Agent |
| 6 Sep 2001 | K012441 | PANAVIA F | EMA Dental Cement |
| 5 Sep 2001 | K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | KLE Resin Tooth Bonding Agent |
| 5 Sep 2001 | K012438 | MODIFICATION TO PANAVIA 21 | EMA Dental Cement |
| 4 Sep 2001 | K012436 | MODIFICATION TO ALLOY PRIMER | KLE Resin Tooth Bonding Agent |
| 4 Sep 2001 | K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Kuraray Noritake Dental, Inc. (18).
Sources
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 of the most recent filing, which can be a US agent.