510(k) Report

FDA applicant

Agion Technologies, LLC

Wakefield, MA1 decision2002–20020 recalls

FDA records 1 decision for Agion Technologies, LLC (Wakefield, MA) in 2002: 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 Agion Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Agion Technologies, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Agion Technologies, LLC 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?

  • K021383Zeodyne Toothbrush with Agion AntimicrobialAgion Technologies, LLC · 2002

The one decision as Agion Technologies, LLC →