K250771
- 510(k) number
- K250771
- Device name
- Primescan 2
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- NTK — Light Transmission Caries Detector
- Decision date
- 2025-08-29
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250771.pdf
Official FDA record: K250771
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.