510(k) Report

FDA applicant

Aribex, Inc.

Orem, UT4 decisions2005–20172 recalls

FDA records 4 decisions for Aribex, Inc. (Orem, UT) from 2005 to 2017: 4 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and IZL (System, X-Ray, Mobile). Its devices cite 4 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Aribex”.

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 Aribex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12014: 12017: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Aribex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aribex, Inc.’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?

  • EHDUnit, X-Ray, Extraoral With Timer3decisions
  • IZLSystem, X-Ray, Mobile1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 2 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.

  • K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 20178cite it
  • K051795Nomad Dental X-Ray SystemAribex, Inc. · 20055cite it
  • K140723Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 20143cite it
  • K081664Nomad Pro X-Ray SystemAribex, Inc. · 20083cite it

What has FDA decided for it lately?

  • K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017
  • K140723Nomad MD 75K V Handheld X-Ray SystemAribex, Inc. · 2014
  • K081664Nomad Pro X-Ray SystemAribex, Inc. · 20082 recalls
  • K051795Nomad Dental X-Ray SystemAribex, Inc. · 2005

All 3 as Aribex, Inc. →The one decision as Aribex →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K081664NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System…Jul 18, 2016Class II
  • K081664NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray…Jul 18, 2016Class II