Data / Medical devices / Japan / Kuraray Noritake Dental Inc. Miyoshi Plant
Kuraray Noritake Dental Inc. Miyoshi Plant: FDA-registered device maker in MIYOSHI Aichi, Japan, 19 510(k) clearances
Kuraray Noritake Dental Inc. Miyoshi Plant is registered with the FDA (registration 9614705) in MIYOSHI Aichi, Japan. It lists 3 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614705
- FEI number
- 3009523116
- Address
- 300 Higashiyama Miyoshi-Cho, MIYOSHI Aichi, Japan, 470-0293
- Owner or operator
- KURARAY NORITAKE DENTAL INC. (10031961)
- Roles
- Manufacturer
- First device listed
- March 25, 2010
- Registered through
- 2026
- Brand names listed
- CERABIEN, CERABIEN MiLai, CERABIEN ZR, CERABIEN ZR SS BASIC FULL KIT, CERABIEN ZR SS ESTHETIC WHITE KIT, CERABIEN ZR TRIAL KIT SS A2, CERABIEN ZR TRIAL KIT SS NV1120, CERABIEN ZR VALUE SHADE FULL KIT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 29, 2025 | K250673 | CERABIEN MiLai | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| May 24, 2024 | K233285 | KATANA Zirconia ONE For IMPLANT | NHA | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| September 23, 2022 | K220369 | Esthetic Colorant | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| March 28, 2022 | K213147 | CERABIEN MiLai | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| January 30, 2020 | K193060 | Noritake Super Porcelain EX-3 | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| May 23, 2019 | K190436 | KATANA Zirconia Block | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| October 17, 2017 | K170834 | CERABIEN ZR | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| February 27, 2015 | K143439 | KATANA Zirconia | EIH | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| June 30, 2011 | K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| November 23, 2005 | K052304 | SUPER PORCELAIN EX-3 PRESS | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| May 11, 2005 | K050920 | CZR PRESS LF STAINS | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| January 11, 2005 | K043462 | CZR PRESS LF | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| October 24, 2003 | K033049 | CZR PRESS | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| September 3, 1999 | K992023 | GRAND CERAM | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| August 27, 1999 | K992024 | SUPER PORCELAIN TI-22 | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| December 22, 1998 | K983470 | SUPER PORCELAIN STAIN- PURE WHITE | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| November 3, 1998 | K983247 | SUPER PORCELAIN ADDMATE | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| October 30, 1998 | K982766 | PASTE OPAQUE EX-3 | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
| January 10, 1989 | K884356 | NORITAKE SUPER PORCELAIN EX-3 | EIH | Substantially Equivalent | Noritake Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Wheel, Polishing Agent
Updated May 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.