510(k) Report

FDA applicant

Castellini S.P.A.

Castel Maggiore, Bologna, IT4 decisions1994–20030 recalls

FDA records 4 decisions for Castellini S.P.A. (Castel Maggiore, Bologna, IT) from 1994 to 2003: 4 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and EHD (Unit, X-Ray, Extraoral With Timer). 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 Castellini S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Castellini S.P.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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