FDA applicant

Ita.O Italian Orthodontic System S.R.L.

Villanova Di Castenaso, IT1 decision2021–20210 recalls

FDA records 1 decision for Ita.O Italian Orthodontic System S.R.L. (Villanova Di Castenaso, IT) in 2021: 1 510(k) clearance. All are in product code DZB (Headgear, Extraoral, Orthodontic). 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 Ita.O Italian Orthodontic System S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ita.O Italian Orthodontic System S.R.L. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ita.O Italian Orthodontic System S.R.L.’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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Ita.O Italian Orthodontic System S.R.L.

Which product codes does it file in?

What has FDA decided for it lately?