Noritake Co., Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Noritake Co., Inc.” (first 1989, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 14 | 14 |
Review panels
- Dental (14)
Most recent Noritake Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111383 | ZIRPRIME | EIH | 2011-08-12 | 87 |
| K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE | EIH | 2011-06-30 | 71 |
| K052304 | SUPER PORCELAIN EX-3 PRESS | EIH | 2005-11-23 | 91 |
| K050920 | CZR PRESS LF STAINS | EIH | 2005-05-11 | 29 |
| K050160 | KATANA ZIRCONIA | EIH | 2005-02-07 | 13 |
| K043462 | CZR PRESS LF | EIH | 2005-01-11 | 27 |
| K031968 | CERABIEN ZR | EIH | 2003-12-22 | 179 |
| K033049 | CZR PRESS | EIH | 2003-10-24 | 25 |
| K992023 | GRAND CERAM | EIH | 1999-09-03 | 79 |
| K992024 | SUPER PORCELAIN TI-22 | EIH | 1999-08-27 | 72 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Noritake Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Noritake Co., Inc.?
FDA lists 14 510(k) clearances under the applicant name “Noritake Co., Inc.” (first 1989, latest 2011), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Noritake Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Noritake Co., Inc. is 76 days.
Which FDA product codes appear under Noritake Co., Inc.?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 14).
Next steps
- See all 14 Noritake Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Noritake Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.