Cleared Traditional

Primescan 2

K250771 · Dentsply Sirona, Inc. · Dental
Aug 2025
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K250771 is an FDA 510(k) clearance for the Primescan 2, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 29, 2025, 169 days after receiving the submission on March 13, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K250771 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date August 29, 2025
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NTK — Caries Detector, Laser Light, Transmission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745