510(k) Report

FDA applicant

Crane Dental Laboratory, Inc.

Rochester, NY2 decisions2014–20190 recalls

FDA records 2 decisions for Crane Dental Laboratory, Inc. (Rochester, NY) from 2014 to 2019: 2 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 2 predicates, 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 Crane Dental Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Crane Dental Laboratory, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc. · 2019
  • K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc. · 2014

All 2 as Crane Dental Laboratory, Inc. →