Durr Dental SE: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Durr Dental SE” (first 2018, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 31 days, against 127 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 62 |
| 2019 | 2 | 26 |
| 2020 | 1 | 113 |
| 2021 | 2 | 91 |
| 2022 | 0 | — |
| 2023 | 2 | 26 |
| 2024 | 0 | — |
| 2025 | 1 | 152 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Durr Dental SE took a median 31 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (9)
Most recent Durr Dental SE 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250947 | VistaSoft 4.0 and VisionX 4.0 | QIH | 2025-08-27 | 152 |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | OAS | 2023-09-14 | 28 |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | MUH | 2023-02-06 | 25 |
| K213326 | VisionX 3.0 | LLZ | 2021-11-02 | 28 |
| K203116 | SensorX | MUH | 2021-03-19 | 154 |
| K193139 | ProVecta 3D Prime Ceph | OAS | 2020-03-05 | 113 |
| K192743 | VisionX 2.4 | LLZ | 2019-10-31 | 31 |
| K190629 | DBSWIN and VISTAEASY Imaging Software | LLZ | 2019-04-01 | 20 |
| K181432 | ProVectra 3D Prime with VistaSoft | OAS | 2018-08-02 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Durr Dental SE.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Durr Dental AG (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Durr Dental SE?
FDA lists 9 510(k) clearances under the applicant name “Durr Dental SE” (first 2018, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Durr Dental SE?
The median time from FDA receipt to decision across 510(k)s cleared under the name Durr Dental SE is 31 days. Since 2017: 31 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Durr Dental SE?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); OAS (X-Ray, Tomography, Computed, Dental, 3); MUH (System, X-Ray, Extraoral Source, Digital, 2).
Next steps
- See all 9 Durr Dental SE clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Durr Dental SE's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.