510(k) Report

FDA applicant

Dental Imagineers, LLC

Ocean, NJ3 decisions1999–20020 recalls

FDA records 3 decisions for Dental Imagineers, LLC (Ocean, NJ) from 1999 to 2002: 3 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 7 predicates, 1 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 Imagineers, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental Imagineers, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental Imagineers, 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?

  • LRKDevice, Anti-Snoring3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K013808SleepbiteDental Imagineers, LLC · 20023cite it
  • K991449Snore-Aid PlusDental Imagineers, LLC · 19991cites it

What has FDA decided for it lately?

  • K022284Snore-Aid MaxDental Imagineers, LLC · 2002
  • K013808SleepbiteDental Imagineers, LLC · 2002
  • K991449Snore-Aid PlusDental Imagineers, LLC · 1999

All 3 as Dental Imagineers, LLC →