K231898
- 510(k) number
- K231898
- Device name
- DTX Studio Clinic (4.0)
- Applicant
- Nobel Biocare AB SE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-12-08
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231898.pdf
Official FDA record: K231898
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.