FirmLabelled 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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Kuraray and its 5 subsidiaries with 123 510(k) clearances. The most recent is a 510(k) clearance dated May 29, 2025: CERABIEN MiLai.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Kuraray and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 29, 2025 | CERABIEN MiLaiK250673 · EIH | 510(k) clearances |
| May 24, 2024 | KATANA Zirconia ONE For IMPLANTK233285 · NHA | 510(k) clearances |
| Dec 13, 2023 | CLEARFIL Universal Bond Quick 2K231039 · KLE | 510(k) clearances |
| Sep 23, 2022 | Esthetic ColorantK220369 · EIH | 510(k) clearances |
| Mar 28, 2022 | CERABIEN MiLaiK213147 · EIH | 510(k) clearances |
| Jun 11, 2021 | PANAVIA Veneer LCK210504 · EMA | 510(k) clearances |
| Jan 30, 2020 | Noritake Super Porcelain EX-3K193060 · EIH | 510(k) clearances |
| Nov 18, 2019 | CLEARFIL MAJESTY ES FlowK191980 · EBF | 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
