510(k) Report

FDA applicant

Frey Oral Technologies, LLC

Beverly Hills, CA1 decision2023–20230 recalls

FDA records 1 decision for Frey Oral Technologies, LLC (Beverly Hills, CA) in 2023: 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 Frey Oral Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Frey Oral Technologies, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Frey Oral Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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:

What has FDA decided for it lately?

  • K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC · 2023

The one decision as Frey Oral Technologies, LLC →