FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Provecta 3D Prime and Provecta 3D Prime Ceph
K Number: K232487
·
Decision Sep 14, 2023
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- Provecta 3D Prime and Provecta 3D Prime Ceph
- K Number
- K232487
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Durr Dental SE
- Date Received
- August 17, 2023
- Decision Date
- September 14, 2023
- Product Code
- OAS
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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Other Clearances by Durr Dental SE
| K Number | Device Name | ||
|---|---|---|---|
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Aug 27, 2025 | Substantially Equivalent |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Feb 6, 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 |