Primescan 2
FDA 510(k) clearance K250771 · decided 2025-08-29
Clearance details
- K-number
- K250771
- Device name
- Primescan 2
- Applicant
- Dentsply Sirona, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-13
- Decision date
- 2025-08-29
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- NTK
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.