510(k) K250771
K250771 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "Primescan 2". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2025
- Date Received
- March 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type