Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ColombiaLabelled 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 New Stetic with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 3, 2026: ZAFIRA®.
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.
| Mar 3, 2026 | ZAFIRA®K254245 · EBF | 510(k) clearances |
| Nov 7, 2019 | Portux CAD/CAM DiscK192153 · EBG | 510(k) clearances |
| Apr 29, 2014 | NEW STETIC DENTAL AMALGAM ALLOYK140125 · OIV | 510(k) clearances |
| Feb 12, 2013 | NEW STETIC ARTIFICIAL TEETHK122925 · ELM | 510(k) clearances |
| Mar 28, 2011 | NEW STETIC ACRYLICSK102874 · 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
