510(k) Report

FDA applicant

Dental Concepts, LLC

Washington, DC3 decisions1984–20060 recalls

FDA records 3 decisions for Dental Concepts, LLC (Washington, DC) from 1984 to 2006: 3 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and JET (Pick, Massaging). 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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Dental Concepts, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental Concepts, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental Concepts, 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?

  • MQCMouthguard, Prescription2decisions
  • JETPick, Massaging1decision

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 10 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.

  • K053580Doctor's NightguardDental Concepts, LLC · 20068cite it
  • K024261Dental ProtectorDental Concepts, LLC · 20032cite it

What has FDA decided for it lately?

  • K053580Doctor's NightguardDental Concepts, LLC · 2006
  • K024261Dental ProtectorDental Concepts, LLC · 2003
  • K844238Orapik Periodontal ScalerDental Concepts, LLC · 1984

All 3 as Dental Concepts, LLC →