Kuraray Noritake Dental, Inc.
New York, NY, US
Kuraray Noritake Dental, Inc. appears in FDA device records in New York, NY. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Kuraray Noritake Dental, Inc. between 2012 and 2025. The busiest year on record is 2013, with 7. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 3 |
| 2013 | 7 |
| 2014 | 1 |
| 2015 | 5 |
| 2016 | 2 |
| 2017 | 2 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250673 | CERABIEN MiLai | EIH | Substantially Equivalent | |
| K233285 | KATANA Zirconia ONE For IMPLANT | NHA | Substantially Equivalent | |
| K231039 | CLEARFIL Universal Bond Quick 2 | KLE | Substantially Equivalent | |
| K220369 | Esthetic Colorant | EIH | Substantially Equivalent | |
| K213147 | CERABIEN MiLai | EIH | Substantially Equivalent | |
| K210504 | PANAVIA Veneer LC | EMA | Substantially Equivalent | |
| K193060 | Noritake Super Porcelain EX-3 | EIH | Substantially Equivalent | |
| K191980 | CLEARFIL MAJESTY ES Flow | EBF | Substantially Equivalent | |
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | PME | Substantially Equivalent | |
| K190436 | KATANA Zirconia Block | EIH | Substantially Equivalent | |
| K182430 | CLEARFIL MAJESTY IC | EBF | Substantially Equivalent | |
| K183537 | PANAVIA SA Cement Universal | EMA | Substantially Equivalent | |
| K170834 | CERABIEN ZR | EIH | Substantially Equivalent | |
| K170986 | KATANA Zirconia Block | EIH | Substantially Equivalent | |
| K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | KLE | Substantially Equivalent | |
| K153476 | KATANA AVENCIA Block | EBF | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | KLE | Substantially Equivalent | |
| K143439 | KATANA Zirconia | EIH | Substantially Equivalent | |
| K142623 | PANAVIA SA Cement Plus Handmix | EMA | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K133211 | ZIRTOUGH | EIH | Substantially Equivalent | |
| K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | KLE | Substantially Equivalent | |
| K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | KLE | Substantially Equivalent | |
| K131534 | KATANA ZIRCONIA | EIH | Substantially Equivalent | |
| K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | KLE | Substantially Equivalent | |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | EJK | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K130371 | CLEARFIL MAJESTY ES FLOW | EBF | Substantially Equivalent | |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | EJK | Substantially Equivalent | |
| K121980 | ZIRPRIME | EIH | Substantially Equivalent | |
| K121583 | CLEARFIL MAJESTY FLOW | EBF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain