510(k) Report

FDA applicant

Duerr Dental AG

Bietigheim-Bissingen, DE3 decisions2016–20170 recalls

FDA records 3 decisions for Duerr Dental AG (Bietigheim-Bissingen, DE) from 2016 to 2017: 3 510(k) clearances. Most are in product codes NTK (Light Transmission Caries Detector) and LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 0 of them its own earlier devices. No 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 Duerr Dental AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2016: 12017: 2
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Duerr Dental AG by year, 2016–2026Sources: 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
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K170733ScanX Intraoral ViewDuerr Dental AG · 20173cite it
  • K172007CamX Triton HD Proxi HeadDuerr Dental AG · 20172cite it
  • K161444DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 20161cites it

What has FDA decided for it lately?

  • K172007CamX Triton HD Proxi HeadDuerr Dental AG · 2017
  • K170733ScanX Intraoral ViewDuerr Dental AG · 2017
  • K161444DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016

All 3 as Duerr Dental AG →