FDA applicant
P&A USA
FDA records 1 decision for P&A USA (Annadale, VA) in 2025: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 2 predicates, 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 P&A USA’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2025high 1 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like P&A USA’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