510(k) Report

FDA applicant

Coe Laboratories, Inc.

Alsip, IL20 decisions1976–19900 recalls

FDA records 20 decisions for Coe Laboratories, Inc. (Alsip, IL) from 1976 to 1990: 20 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). 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 Coe Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coe Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Coe Laboratories, Inc.’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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