510(k) Report

FDA applicant

P&A USA

Annadale, VA1 decision2025–20250 recalls

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, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided P&A USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — P&A USA by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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