# K253959: Primevision 3D

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Feb 5, 2026 after 57 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K973642 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201140: Axeos, Dentsply Sirona (2020) Summary page 5.

## Indications for use
The X-ray system creates data for digital exposures in the maxillofacial area and in sub-areas for dentistry and pediatric dentistry and for hard tissue diagnostics within ENT medicine.

Source page: https://510kreport.com/device/K253959
Methodology: https://510kreport.com/methodology