FDA applicant
W&H Dentalwerk Buermoos GmbH
FDA records 18 decisions for W&H Dentalwerk Buermoos GmbH (Buermoos, AT) from 1999 to 2026: 18 510(k) clearances. Most are in product codes EBW (Controller, Foot, Handpiece And Cord) and EFB (Handpiece, Air-Powered, Dental). Its devices cite 21 predicates, 8 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 W&H Dentalwerk Buermoos GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like W&H Dentalwerk Buermoos 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