510(k) Report

FDA applicant

Titane SL Co.

Minneapolis, MN1 decision1987–19870 recalls

FDA records 1 decision for Titane SL Co. (Minneapolis, MN) in 1987: 1 510(k) clearance. All are in product code ECM (Band, Preformed, 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 Titane SL Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Titane SL Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Titane SL Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Titane SL Co.’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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