Cleared Traditional

K250771 - Primescan 2

K250771 is an FDA 510(k) clearance for Primescan 2, manufactured by Dentsply Sirona, Inc.. The device is a Class 2 Dental device with product code NTK cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K250771 · Dentsply Sirona, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
169d
Days
Class 2
Risk

K250771 is an FDA 510(k) clearance for the Primescan 2. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 29, 2025 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona, Inc. devices

FDA 510(k) Submission Details - K250771

510(k) Number K250771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NTK Device Classification - Class 2, Special Controls

Product Code NTK Caries Detector, Laser Light, Transmission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NTK Caries Detector, Laser Light, Transmission

All 9
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