510(k) Report

FDA applicant

Ottawa Dental Laboratory

Crofton, MD1 decision2004–20040 recalls

FDA records 1 decision for Ottawa Dental Laboratory (Crofton, MD) in 2004: 1 510(k) clearance. All are in product code LRK (Device, Anti-Snoring). 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 Ottawa Dental Laboratory’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ottawa Dental Laboratory since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ottawa Dental Laboratory by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ottawa Dental Laboratory’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?

  • LRKDevice, Anti-Snoring1decision

What has FDA decided for it lately?

  • K021569Restful Nights, Ist-ApplianceOttawa Dental Laboratory · 2004

The one decision as Ottawa Dental Laboratory →