FDA applicant

Leone S.P.A.

Sesto, Fiorentino, IT4 decisions2006–20250 recalls

FDA records 4 decisions for Leone S.P.A. (Sesto, Fiorentino, IT) from 2006 to 2025: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 6 predicates, 1 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 Leone S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leone S.P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leone S.P.A.’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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Leone S.P.A.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?