510(k) Report

FDA applicant

Gendex Dental Systems

Des Plaines, IL2 decisions2005–20063 recalls

FDA records 2 decisions for Gendex Dental Systems (Des Plaines, IL) from 2005 to 2006: 2 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are 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 Gendex Dental Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gendex Dental Systems since 2007.

Recalls per year

1in 2011

2009: 12010: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gendex Dental Systems 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?

  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 7 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.

  • K060178Vix Win ProGendex Dental Systems · 20066cite it
  • K050255Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4Gendex Dental Systems · 20051cites it

What has FDA decided for it lately?

  • K060178Vix Win ProGendex Dental Systems · 20061 recall
  • K050255Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4Gendex Dental Systems · 20052 recalls

All 2 as Gendex Dental Systems →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K050255Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer…Feb 4, 2011
  • K050255Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer…Dec 21, 2010
  • K060178Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental…Mar 6, 2009

Other applicant names beginning “Gendex”

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

Gendex Corp. 14