510(k) Report

FDA applicant

Azo Enterprises

Chicago, IL1 decision1999–19990 recalls

FDA records 1 decision for Azo Enterprises (Chicago, IL) in 1999: 1 510(k) clearance. All are in product code EFW (Toothbrush, Manual). 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 Azo Enterprises’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Azo Enterprises since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • EFWToothbrush, Manual1decision

What has FDA decided for it lately?

  • K992435Bacti-Stop Toothbrush Cleaner and SanitizerAzo Enterprises · 1999

The one decision as Azo Enterprises →