Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Dentsply SironaLabelled 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 Dentply International, Inc. with 1 510(k) clearance. The most recent is a 510(k) clearance dated Mar 4, 2016: Aquasil Ultra + Smart Wetting Impression Material.
| Date | Record | Source |
|---|---|---|
| Mar 4, 2016 | Aquasil Ultra + Smart Wetting Impression MaterialK152861 ยท ELW | 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
