# K181432: ProVectra 3D Prime with VistaSoft

- Pathway: 510(k) (Traditional)
- Applicant: Durr Dental SE
- Decided: Aug 2, 2018 after 62 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: 8 generations back to K973642 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart, VATECH Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K200270: rainbow MCT (2021), 0 descendants of its own

## Indications for use
ProVecta 3D Prime: ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use. VistaSoft: The VistaSoft software features functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.

Source page: https://510kreport.com/device/K181432
Methodology: https://510kreport.com/methodology