510(k) Report

FDA applicant

Neks Technologies, Inc.

Laval, Quebec, CA3 decisions2003–20070 recalls

FDA records 3 decisions for Neks Technologies, Inc. (Laval, Quebec, CA) from 2003 to 2007: 3 510(k) clearances. Most are in product codes NBL (Light-Induced Fluorescence Caries Detector) and EJB (Handle, Instrument, Dental). Its devices cite 9 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neks Technologies”.

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

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Neks Technologies, 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?

  • NBLLight-Induced Fluorescence Caries Detector2decisions
  • EJBHandle, Instrument, Dental1decision

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K023367Detectar, Model N123-MINeks Technologies · 20033cite it
  • K043156D-Carie, Model N121-M1Neks Technologies, Inc. · 20051cites it

What has FDA decided for it lately?

  • K063321D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138Neks Technologies, Inc. · 2007
  • K043156D-Carie, Model N121-M1Neks Technologies, Inc. · 2005
  • K023367Detectar, Model N123-MINeks Technologies · 2003

All 2 as Neks Technologies, Inc. →The one decision as Neks Technologies →