Kuraray Noritake Dental, Inc.: FDA clearances and approvals
Kuraray Noritake Dental, Inc. has 32 FDA 510(k) clearances (first 2012, latest 2025), across 7 product codes in 1 review panel. Median 510(k) review time: 130 days. Since 2017 its median was 144 days, against 135 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 105 |
| 2013 | 7 | 97 |
| 2014 | 1 | 153 |
| 2015 | 5 | 148 |
| 2016 | 2 | 230 |
| 2017 | 2 | 156 |
| 2018 | 0 | — |
| 2019 | 5 | 127 |
| 2020 | 1 | 90 |
| 2021 | 1 | 109 |
| 2022 | 2 | 204 |
| 2023 | 1 | 245 |
| 2024 | 1 | 238 |
| 2025 | 1 | 84 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Kuraray Noritake Dental, Inc.'s cleared 510(k)s took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 11 | 11 |
| KLE | Agent, Tooth Bonding, Resin | 7 | 7 |
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| EMA | Cement, Dental | 5 | 5 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
| PME | External Cleaning Solution | 1 | 1 |
Review panels
- Dental (32)
Most recent Kuraray Noritake Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250673 | CERABIEN MiLai | EIH | 2025-05-29 | 84 |
| K233285 | KATANA Zirconia ONE For IMPLANT | NHA | 2024-05-24 | 238 |
| K231039 | CLEARFIL Universal Bond Quick 2 | KLE | 2023-12-13 | 245 |
| K220369 | Esthetic Colorant | EIH | 2022-09-23 | 227 |
| K213147 | CERABIEN MiLai | EIH | 2022-03-28 | 182 |
| K210504 | PANAVIA Veneer LC | EMA | 2021-06-11 | 109 |
| K193060 | Noritake Super Porcelain EX-3 | EIH | 2020-01-30 | 90 |
| K191980 | CLEARFIL MAJESTY ES Flow | EBF | 2019-11-18 | 117 |
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | PME | 2019-10-08 | 162 |
| K190436 | KATANA Zirconia Block | EIH | 2019-05-23 | 90 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kuraray Noritake Dental, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kuraray Noritake Dental, Inc. have?
Kuraray Noritake Dental, Inc. has 32 FDA 510(k) clearances (first 2012, latest 2025), across 7 product codes in 1 review panel.
How long does FDA take to clear Kuraray Noritake Dental, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kuraray Noritake Dental, Inc.'s cleared 510(k)s is 130 days. Since 2017: 144 days, versus 135 days for all cleared 510(k)s in the same product codes.
What devices does Kuraray Noritake Dental, Inc. make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 11); KLE (Agent, Tooth Bonding, Resin, 7); EBF (Material, Tooth Shade, Resin, 5).
Has Kuraray Noritake Dental, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kuraray Noritake Dental, Inc. Related entities may recall under other names.
Next steps
- See all 32 Kuraray Noritake Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Kuraray Noritake Dental, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.