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., 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 Sirona Dental Systems with 42 510(k) clearances. The most recent is a 510(k) clearance dated Jun 2, 2016: CEREC SpeedGlaze.
| Jun 2, 2016 | CEREC SpeedGlazeK160099 · EIH | 510(k) clearances |
| Jul 24, 2015 | TENEO Dental Treatment Unit and AccessoriesK151045 · EIA | 510(k) clearances |
| Jul 17, 2015 | INTEGO Family and AccesoriesK150909 · EIA | 510(k) clearances |
| Jul 2, 2015 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayK150750 · EGS | 510(k) clearances |
| May 8, 2015 | ORTHOPHOS SLK150217 · OAS | 510(k) clearances |
| May 30, 2014 | T1/T2/T3 TURBINE FAMILYK131319 · EFB | 510(k) clearances |
| Dec 11, 2013 | SIDEXIS 4K132773 · LLZ | 510(k) clearances |
| Apr 8, 2013 | INCORIS ZIK123664 · EIH | 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
