Medical device makerLabelled 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 14, 2026, FDA's public records list Datum Dental, Ltd. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 29, 2026: OSSIX Plus.
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.
| Oct 29, 2026 | OSSIX PlusK262415 · NPL | 510(k) clearances |
| Jul 18, 2022 | OSSIX BreezeK212509 · NPL | 510(k) clearances |
| Jul 18, 2017 | OSSIX BONEK163714 · NPM | 510(k) clearances |
| Aug 4, 2016 | OSSIX VOLUMAXK153549 · NPL | 510(k) clearances |
| Aug 4, 2016 | OSSIX PLUSK160281 · NPL | 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
