FDA applicant
B&W Srl
FDA records 1 decision for B&W Srl (Buenos Aires, AR) in 2012: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). 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 B&W Srl’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2012high 1 (2012) · low 0 (2013)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like B&W Srl’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