Tokuyama Dental Corporation: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Tokuyama Dental Corporation” (first 2003, latest 2021), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 153 days, against 116 days for all cleared 510(k)s in the same product codes. 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 | 1 | 89 |
| 2016 | 0 | — |
| 2017 | 3 | 216 |
| 2018 | 2 | 132 |
| 2019 | 1 | 177 |
| 2020 | 1 | 243 |
| 2021 | 2 | 104 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tokuyama Dental Corporation took a median 153 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 9 | 9 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EMA | Cement, Dental | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (19)
Most recent Tokuyama Dental Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203760 | Tokuyama Universal Bond II | KLE | 2021-05-25 | 153 |
| K203598 | Omnichroma Flow Bulk | EBF | 2021-02-03 | 56 |
| K193537 | Omnichroma Flow | EBF | 2020-08-19 | 243 |
| K190940 | Tokuyama Rebase III | EBI | 2019-10-04 | 177 |
| K180613 | Estelite Universal Flow | EBF | 2018-07-12 | 126 |
| K173275 | OMNICHROMA | EBF | 2018-02-27 | 138 |
| K171226 | TOKUYAMA UNIVERSAL BOND | KLE | 2017-11-28 | 216 |
| K170549 | TOKUYAMA CUREGRACE | EBI | 2017-07-05 | 131 |
| K161353 | ESTELITE BULK FILL Flow | EBF | 2017-04-03 | 322 |
| K150727 | ESTECEM | EMA | 2015-06-17 | 89 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tokuyama Dental Corporation.
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 America, Inc. (22 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tokuyama Dental Corporation?
FDA lists 19 510(k) clearances under the applicant name “Tokuyama Dental Corporation” (first 2003, latest 2021), across 5 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 Dental Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tokuyama Dental Corporation is 126 days. Since 2017: 153 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tokuyama Dental Corporation?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 9); EBI (Resin, Denture, Relining, Repairing, Rebasing, 5); KLE (Agent, Tooth Bonding, Resin, 3).
Next steps
- See all 19 Tokuyama Dental Corporation clearances with predicates and recalls
- Run predicate analysis for product code EBF, Tokuyama Dental Corporation'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.