K232487
- 510(k) number
- K232487
- Device name
- Provecta 3D Prime and Provecta 3D Prime Ceph
- Applicant
- Durr Dental SE DE
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2023-09-14
- Date received
- 2023-08-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232487.pdf
Official FDA record: K232487
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.