510(k) Report

FDA applicant

The Smylon Co.

Los Angeles, CA1 decision1989–19890 recalls

FDA records 1 decision for The Smylon Co. (Los Angeles, CA) in 1989: 1 510(k) clearance. All are in product code MAU (Eraser, Dental Stain). 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 The Smylon Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Smylon Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The Smylon 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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