510(k) Report

FDA applicant

Glidewell Laboratories

Newport Beach, CA3 decisions1997–20061 recall

FDA records 3 decisions for Glidewell Laboratories (Newport Beach, CA) from 1997 to 2006: 3 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and LRK (Device, Anti-Snoring). 1 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 Glidewell Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glidewell Laboratories since 2007.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Glidewell Laboratories 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?

  • EIHPowder, Porcelain2decisions
  • LRKDevice, Anti-Snoring1decision

Who builds on its devices?

Later devices cite its devices 12 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.

  • K972424SilentniteGlidewell Laboratories · 19976cite it
  • K060104Prismatik Clinical ZirconiaGlidewell Laboratories · 20065cite it
  • K050144Prismatik CeramicGlidewell Laboratories · 20051cites it

What has FDA decided for it lately?

  • K060104Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
  • K050144Prismatik CeramicGlidewell Laboratories · 2005
  • K972424SilentniteGlidewell Laboratories · 19971 recall

All 3 as Glidewell Laboratories →

What has been recalled?

1 recall linked to its devices; the latest:

  • K183270Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number…Apr 27, 2026Class II

Other applicant names beginning “Glidewell”

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

Glidewell Laboratories-Sleep Devices Group 1