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 Dentsply Interntional with 13 510(k) clearances. The most recent is a 510(k) clearance dated Dec 2, 2009: X-SMART EASY.
| Dec 2, 2009 | X-SMART EASYK092614 · EKX | 510(k) clearances |
| Jul 24, 2009 | ELATION MB METAL REINFORCED PLASTIC BRACKETK092030 · DYW | 510(k) clearances |
| Mar 20, 2009 | ALLURE MB CERAMIC BRACKETSK090454 · NJM | 510(k) clearances |
| Jan 29, 2009 | STER-MATE STERILE LAVAGE KITK082973 · ELC | 510(k) clearances |
| Nov 7, 2008 | MYSTIQUE MB CERAMIC BRACKETSK082974 · NJM | 510(k) clearances |
| May 22, 2008 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSIONK081291 · DYH | 510(k) clearances |
| Apr 18, 2008 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEMK080311 · EBG | 510(k) clearances |
| Apr 11, 2008 | COMPOSITE ALIGNER BUTTONK080246 · NXC | 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
