Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Durr Dental SE — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
152 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025-08-27 | 152 | 0 |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | 2023-09-14 | 28 | 0 |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023-02-06 | 25 | 0 |
| K213326 | VisionX 3.0 | Durr Dental SE | 2021-11-02 | 28 | 0 |
| K203116 | SensorX | Durr Dental SE | 2021-03-19 | 154 | 0 |
| K203287 | DBSWIN, VISTAEASY | Dürr Dental SE | 2020-11-18 | 9 | 0 |
| K202633 | ScanX Edge | Dürr Dental SE | 2020-10-07 | 26 | 0 |
| K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | 2020-03-05 | 113 | 0 |
| K192743 | VisionX 2.4 | Durr Dental SE | 2019-10-31 | 31 | 0 |
| K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019-04-01 | 20 | 0 |
| K181432 | ProVectra 3D Prime with VistaSoft | Durr Dental SE | 2018-08-02 | 62 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda