FDA applicant

Ortosim, S.A. DE C.V.

Littleton, CO1 decision2003–20030 recalls

FDA records 1 decision for Ortosim, S.A. DE C.V. (Littleton, CO) in 2003: 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 Ortosim, S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortosim, S.A. DE C.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ortosim, S.A. DE C.V.

Which product codes does it file in?

What has FDA decided for it lately?