Not currently registered with FDA under this name
Kuraray America, Inc.
New York, NY, United States. Named as applicant on 11 dental 510(k) clearances between 1997 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 111997–2011
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Kuraray America, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Nov 2011 | K111982 | CLEARFIL DC CORE PLUS | EBF Resin Tooth Shade Material |
| 14 Oct 2011 | K111980 | CLEARFIL TRI-S BOND PLUS | KLE Resin Tooth Bonding Agent |
| 9 Feb 2007 | K063595 | CLEARFIL MAJESTY POSTERIOR | EBF Resin Tooth Shade Material |
| 2 Feb 2007 | K063593 | CLEARFIL MAJESTY FLOW | EBF Resin Tooth Shade Material |
| 8 Dec 2006 | K063228 | SURFACE COAT | EBD Resin Filling Material Coating |
| 18 Sep 2000 | K002322 | MODIFICATION TO PANAVIA F | EMA Dental Cement |
| 13 Nov 1998 | K983361 | PANAVIA F | EMA Dental Cement |
| 22 Sep 1998 | K982259 | CHROMA ZONE COLOR STAIN | EBF Resin Tooth Shade Material |
| 10 Aug 1998 | K982164 | ESTENIA | EBF Resin Tooth Shade Material |
| 29 Jan 1998 | K974486 | CLEARFIL LINER BOND 2V | KLE Resin Tooth Bonding Agent |
| 17 Dec 1997 | K974089 | ALLOY PRIMER | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Kuraray Noritake Dental, Inc. (3), Xplora USA LLC (1).
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.