510(k) Report

FDA applicant

Durr Dental SE

Bietigheim-Bissingen, DE14 decisions2016–20260 recalls

FDA records 14 decisions for Durr Dental SE (Bietigheim-Bissingen, DE) from 2016 to 2026: 14 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and OAS (X-Ray, Tomography, Computed, Dental). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dürr Dental SE”, “Durr Dental AG”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Durr Dental SE’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 22018: 12019: 22020: 32021: 22023: 22025: 12026 (partial year): 1
2016high 3 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Durr Dental SE by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Durr Dental SE’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological5decisions
  • OASX-Ray, Tomography, Computed, Dental3decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital3decisions
  • NBLLight-Induced Fluorescence Caries Detector1decision
  • QIHAutomated Radiological Image Processing Software1decision
  • PEMDental Barriers And Sleeves1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 7 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 6 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.

  • K150672VistaCam iX ProofDurr Dental AG · 20163cite it
  • K193139ProVecta 3D Prime CephDurr Dental SE · 20202cite it
  • K190629DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 20192cite it
  • K181432ProVectra 3D Prime with VistaSoftDurr Dental SE · 20181cites it
  • K213326VisionX 3.0Durr Dental SE · 20211cites it
  • K202633ScanX EdgeDürr Dental SE · 20201cites it

What has FDA decided for it lately?

  • K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE · 2026
  • K250947VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
  • K232487Provecta 3D Prime and Provecta 3D Prime CephDurr Dental SE · 2023
  • K230095ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023
  • K213326VisionX 3.0Durr Dental SE · 2021
  • K203116SensorXDurr Dental SE · 2021
  • K203287Dbswin, VistaeasyDürr Dental SE · 2020
  • K202633ScanX EdgeDürr Dental SE · 2020

All 9 as Durr Dental SE →All 3 as Dürr Dental SE →All 2 as Durr Dental AG →