Company ยท JP
Kuraray Noritake Dental, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2025 | K250673 | CERABIEN MiLai Kuraray Noritake Dental, Inc., JP | EIH |
| May 24, 2024 | K233285 | KATANA Zirconia ONE For IMPLANT Kuraray Noritake Dental, Inc., JP | NHA |
| Dec 13, 2023 | K231039 | CLEARFIL Universal Bond Quick 2 Kuraray Noritake Dental, Inc., JP | KLE |
| Sep 23, 2022 | K220369 | Esthetic Colorant Kuraray Noritake Dental, Inc., JP | EIH |
| Mar 28, 2022 | K213147 | CERABIEN MiLai Kuraray Noritake Dental, Inc., JP | EIH |
| Jun 11, 2021 | K210504 | PANAVIA Veneer LC Kuraray Noritake Dental, Inc., JP | EMA |
| Jan 30, 2020 | K193060 | Noritake Super Porcelain EX-3 Kuraray Noritake Dental, Inc., JP | EIH |
| Nov 18, 2019 | K191980 | CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental, Inc., JP | EBF |
| Oct 8, 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) Kuraray Noritake Dental, Inc., JP | PME |
| May 23, 2019 | K190436 | KATANA Zirconia Block Kuraray Noritake Dental, Inc., JP | EIH |
| May 3, 2019 | K182430 | CLEARFIL MAJESTY IC Kuraray Noritake Dental, Inc., JP | EBF |
| Apr 25, 2019 | K183537 | PANAVIA SA Cement Universal Kuraray Noritake Dental, Inc., JP | EMA |
| Oct 17, 2017 | K170834 | CERABIEN ZR Kuraray Noritake Dental, Inc., JP | EIH |
| Jul 13, 2017 | K170986 | KATANA Zirconia Block Kuraray Noritake Dental, Inc., JP | EIH |
| Oct 25, 2016 | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Kuraray Noritake Dental, Inc., JP | KLE |
| Aug 23, 2016 | K153476 | KATANA AVENCIA Block Kuraray Noritake Dental, Inc., JP | EBF |
| Aug 21, 2015 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Cl Kuraray Noritake Dental, Inc., JP | EMA |
| Aug 13, 2015 | K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) Kuraray Noritake Dental, Inc., JP | KLE |
| Feb 27, 2015 | K143439 | KATANA Zirconia Kuraray Noritake Dental, Inc., JP | EIH |
| Feb 26, 2015 | K142623 | PANAVIA SA Cement Plus Handmix Kuraray Noritake Dental, Inc., JP | EMA |
| Jan 27, 2015 | K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Tr Kuraray Noritake Dental, Inc., JP | EMA |
| Mar 20, 2014 | K133211 | ZIRTOUGH Kuraray Noritake Dental, Inc. | EIH |
| Dec 20, 2013 | K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) Kuraray Noritake Dental, Inc., JP | KLE |
| Nov 1, 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND Kuraray Noritake Dental, Inc., JP | KLE |
| Oct 11, 2013 | K131534 | KATANA ZIRCONIA Kuraray Noritake Dental, Inc. | EIH |
| Aug 30, 2013 | K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL Kuraray Noritake Dental, Inc., JP | KLE |
| Aug 27, 2013 | K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID Kuraray Noritake Dental, Inc., JP | EJK |
| Aug 22, 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 Kuraray Noritake Dental, Inc., JP | KLE |
| Apr 9, 2013 | K130371 | CLEARFIL MAJESTY ES FLOW Kuraray Noritake Dental, Inc., JP | EBF |
| Dec 11, 2012 | K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID Kuraray Noritake Dental, Inc., JP | EJK |
| Oct 19, 2012 | K121980 | ZIRPRIME Kuraray Noritake Dental, Inc. | EIH |
| Jul 25, 2012 | K121583 | CLEARFIL MAJESTY FLOW Kuraray Noritake Dental, Inc. | EBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||