510(k) Report

FDA applicant

D4D Technologies, LLC

Richardson, TX2 decisions2011–20220 recalls

FDA records 2 decisions for D4D Technologies, LLC (Richardson, TX) from 2011 to 2022: 2 510(k) clearances. Most are in product codes NTK (Light Transmission Caries Detector) and LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “D4D 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 D4D Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011: 12022: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — D4D Technologies, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NTKLight Transmission Caries Detector1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC · 2022
  • K110511E4D CompassD4D Technologies · 2011

The one decision as D4D Technologies, LLC →The one decision as D4D Technologies →