510(k) Report

FDA applicant

Glidewell Laboratories-Sleep Devices Group

Irvine, CA1 decision2012–20120 recalls

FDA records 1 decision for Glidewell Laboratories-Sleep Devices Group (Irvine, CA) in 2012: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). Its devices cite 3 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

How often FDA has decided Glidewell Laboratories-Sleep Devices Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Glidewell Laboratories-Sleep Devices Group by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glidewell Laboratories-Sleep Devices…’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?

  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group · 20122cite it

What has FDA decided for it lately?

  • K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group · 2012

The one decision as Glidewell Laboratories-Sleep Devices Group →

Other applicant names beginning “Glidewell”

FDA records each applicant name separately; these may or may not be the same firm.

Glidewell Laboratories 3