Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Tokuyama CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Tokuyama Dental with 19 510(k) clearances. The most recent is a 510(k) clearance dated May 25, 2021: Tokuyama Universal Bond II.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 25, 2021 | Tokuyama Universal Bond IIK203760 · KLE | 510(k) clearances |
| Feb 3, 2021 | Omnichroma Flow BulkK203598 · EBF | 510(k) clearances |
| Aug 19, 2020 | Omnichroma FlowK193537 · EBF | 510(k) clearances |
| Oct 4, 2019 | Tokuyama Rebase IIIK190940 · EBI | 510(k) clearances |
| Jul 12, 2018 | Estelite Universal FlowK180613 · EBF | 510(k) clearances |
| Feb 27, 2018 | OMNICHROMAK173275 · EBF | 510(k) clearances |
| Nov 28, 2017 | TOKUYAMA UNIVERSAL BONDK171226 · KLE | 510(k) clearances |
| Jul 5, 2017 | TOKUYAMA CUREGRACEK170549 · EBI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
