510(k) Report

FDA applicant

Randmark Dental Products, LLC

Potomac, MD1 decision2011–20110 recalls

FDA records 1 decision for Randmark Dental Products, LLC (Potomac, MD) in 2011: 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 Randmark Dental Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Randmark Dental Products, LLC by year, 2011–2026Sources: 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 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.

  • K110468Freeway Comfort Bite GuardRandmark Dental Products, LLC · 20111cites it

What has FDA decided for it lately?

  • K110468Freeway Comfort Bite GuardRandmark Dental Products, LLC · 2011

The one decision as Randmark Dental Products, LLC →