510(k) Report

FDA applicant

Zygomatics, Ltd.

London Se3 0ta, GB1 decision2003–20030 recalls

FDA records 1 decision for Zygomatics, Ltd. (London Se3 0ta, GB) in 2003: 1 510(k) clearance. All are in product code DYX (Lock, Wire, And Ligature, Intraoral). 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 Zygomatics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zygomatics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zygomatics, Ltd. 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?

  • DYXLock, Wire, And Ligature, Intraoral1decision

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.

  • K030605Rapid ImfZygomatics, Ltd. · 20031cites it

What has FDA decided for it lately?

  • K030605Rapid ImfZygomatics, Ltd. · 2003

The one decision as Zygomatics, Ltd. →