510(k) Report

FDA applicant

Mci-Myohealth Systems

Mission Viejo, CA1 decision2004–20040 recalls

FDA records 1 decision for Mci-Myohealth Systems (Mission Viejo, CA) in 2004: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). Its devices cite 1 predicate, 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

How often FDA has decided Mci-Myohealth Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mci-Myohealth Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mci-Myohealth Systems 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?

  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K040315Myohealth Clenching InhibitorMci-Myohealth Systems · 20043cite it

What has FDA decided for it lately?

  • K040315Myohealth Clenching InhibitorMci-Myohealth Systems · 2004

The one decision as Mci-Myohealth Systems →