Tokuyama America, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Tokuyama America, Inc.” (first 1990, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 10 | 10 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EMA | Cement, Dental | 3 | 3 |
Review panels
- Dental (22)
Most recent Tokuyama America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022641 | TOKUYAMA REBASE II | EBI | 2002-10-02 | 55 |
| K011854 | TOKUYAMA M-BOND | EMA | 2001-09-04 | 83 |
| K011685 | BISTITE II DC | EMA | 2001-07-31 | 61 |
| K010267 | PALFIQUE ESTELITE LV CLEAR | EBF | 2001-02-27 | 29 |
| K002863 | PALFIQUE ESTELITE LV | EBF | 2001-01-04 | 113 |
| K993917 | TOKUYAMA ONE-UP-BOND F | KLE | 2000-02-02 | 77 |
| K991711 | BISTITE II SC | EMA | 1999-07-07 | 49 |
| K982537 | TOKUYAMA SOFRELINER | EBI | 1998-08-24 | 34 |
| K980058 | TOKUSO MAC BOND II | EBF | 1998-04-27 | 111 |
| K980054 | PALFIQUE ESTELITE | EBF | 1998-04-27 | 111 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tokuyama America, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tokuyama Dental Corporation (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tokuyama America, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Tokuyama America, Inc.” (first 1990, latest 2002), across 4 product codes 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 Tokuyama America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tokuyama America, Inc. is 82 days.
Which FDA product codes appear under Tokuyama America, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 10); EBI (Resin, Denture, Relining, Repairing, Rebasing, 5); KLE (Agent, Tooth Bonding, Resin, 4).
Next steps
- See all 22 Tokuyama America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Tokuyama America, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.