FDA applicant
W&H Dentalwerk Bürmoos GmbH
FDA records 5 decisions for W&H Dentalwerk Bürmoos GmbH (Buermoos, AT) from 2004 to 2026: 5 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and EBW (Controller, Foot, Handpiece And Cord). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “W&H Dentalwerk Burmoos GmbH”, “W&H Dentalwerk Burmoos”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided W&H Dentalwerk Bürmoos GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like W&H Dentalwerk Bürmoos 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