510(k) Report

FDA applicant

Coronet Group North America, LLC

Queensbury,, NY1 decision2002–20020 recalls

FDA records 1 decision for Coronet Group North America, LLC (Queensbury,, NY) in 2002: 1 510(k) clearance. All are in product code EFW (Toothbrush, Manual). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Coronet Group North America, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coronet Group North America, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coronet Group North America, 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020776Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 20021cites it

What has FDA decided for it lately?

  • K020776Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002

The one decision as Coronet Group North America, LLC →