FDA applicant
Dentsply Intl.
FDA records 291 decisions for Dentsply Intl. (York, PA) from 1976 to 2014: 291 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EIH (Powder, Porcelain). Its devices cite 127 predicates, 65 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Dentsply Intl., Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dentsply Intl.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Dentsply Intl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Dentsply”
FDA records each applicant name separately; these may or may not be the same firm.