FDA applicant
Espe GmbH (Us)
FDA records 59 decisions for Espe GmbH (Us) (Lake Worth, FL) from 1977 to 1993: 59 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Espe GmbH (Us)’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Espe GmbH (Us) since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Espe GmbH (Us)’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.