FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ScanX Swift 2.0, ScanX Swift View 2.0
K Number: K230095
·
Decision Feb 6, 2023
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
9
Review Days
25
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Basic Information
- Device Name
- ScanX Swift 2.0, ScanX Swift View 2.0
- K Number
- K230095
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Durr Dental SE
- Date Received
- January 12, 2023
- Decision Date
- February 6, 2023
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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|---|---|---|---|
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| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Sep 14, 2023 | Substantially Equivalent |
| K213326 | VisionX 3.0 | Nov 2, 2021 | Substantially Equivalent |
| K203116 | SensorX | Mar 19, 2021 | Substantially Equivalent |
| K193139 | ProVecta 3D Prime Ceph | Mar 5, 2020 | Substantially Equivalent |
| K192743 | VisionX 2.4 | Oct 31, 2019 | Substantially Equivalent |
| K190629 | DBSWIN and VISTAEASY Imaging Software | Apr 1, 2019 | Substantially Equivalent |
| K181432 | ProVectra 3D Prime with VistaSoft | Aug 2, 2018 | Substantially Equivalent |