Class Class II
ScanX Swift 2.0, ScanX Swift View 2.0 (K230095)
Description
ScanX Swift 2.0, ScanX Swift View 2.0 by Durr Dental SE, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230095
Clearance Date2023-02-06
Clearance TypeSpecial
Product CodeMUH
Regulation Number872.1800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230095
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ScanX Swift 2.0, ScanX Swift View 2.0 (K230095) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213326 | VisionX 3.0 | Durr Dental SE | 2021 |
| K203287 | DBSWIN, VISTAEASY | Dürr Dental SE | 2020 |
| K202633 | ScanX Edge | Dürr Dental SE | 2020 |
Trace the full predicate network for K230095
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.