FDA applicant
Espe Dental AG
FDA records 29 decisions for Espe Dental AG (Bavaria D-82228 Seefeld, DE) from 1998 to 2001: 29 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). Its devices cite 45 predicates, 6 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Espe Dental AG’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Espe Dental AG since 2007.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Espe Dental AG’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 “Espe”
FDA records each applicant name separately; these may or may not be the same firm.