FDA applicant
Edelweiss Dentistry Products GmbH
FDA records 1 decision for Edelweiss Dentistry Products GmbH (Wolfurt, AT) in 2024: 1 510(k) clearance. All are in product code EBF (Material, Tooth Shade, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Edelweiss Dentistry Products GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Edelweiss Dentistry Products GmbH’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