Primescan 2
FDA 510(k) K250771 · Dentsply Sirona, Inc.
510(k) numberK250771
Submission
- Device name
- Primescan 2
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- March 13, 2025
- Decision date
- August 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Primescan 2 cleared by the FDA?
Primescan 2 (K250771) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 169 days after the submission was received.
What is the product code of K250771?
The FDA product code is NTK – Light Transmission Caries Detector, a Class II (moderate risk) device regulated under 21 CFR 872.1745.