# K250771: Primescan 2

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Aug 29, 2025 after 169 days
- Product code: NTK (Light Transmission Caries Detector)
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933455 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182712: DEXIS CariVu 3-in-1 by KaVo, Kaltenbach & Voigt GmbH (2019) Summary page 5.

## Indications for use
Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

Source page: https://510kreport.com/device/K250771
Methodology: https://510kreport.com/methodology