FDA applicant
European Dental Imports, Inc.
FDA records 7 decisions for European Dental Imports, Inc. (Durham, NH) in 1998: 7 510(k) clearances. Most are in product codes EJS (Alloy, Other Noble Metal) and EJT (Alloy, Gold-Based Noble Metal). 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 European Dental Imports, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for European Dental Imports, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like European Dental Imports, Inc.’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) Report