Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled 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 15, 2026, FDA's public records list Dreve Dentamid with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 7, 2025: Primeprint Direct Aligner.
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.
| Nov 7, 2025 | Primeprint Direct AlignerK250739 · NXC | 510(k) clearances |
| May 31, 2024 | Fixtemp® C&B 4:1K241226 · EBG | 510(k) clearances |
| Nov 19, 2020 | FotoDent dentureK200580 · EBI | 510(k) clearances |
| Nov 7, 2019 | StoneBite and StoneBite scanK190571 · ELW | 510(k) clearances |
| Apr 13, 2018 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoK171562 · ELW | 510(k) clearances |
| Apr 5, 2018 | Nano Varnish, Plaquit, Lightpaint on SurfaceK162408 · EBD | 510(k) clearances |
| Dec 13, 2017 | Fixtemp C&BK171729 · EBG | 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
