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510(k) K250771

Primescan 2 by Dentsply Sirona, Inc. — Product Code NTK

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
Caries Detector, Laser Light, Transmission
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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