# K193139: ProVecta 3D Prime Ceph

- Pathway: 510(k) (Traditional)
- Applicant: Durr Dental SE
- Decided: Mar 5, 2020 after 113 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart, VATECH Co., Ltd. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K200271: rainbow CT (2021), 1 descendant of its own
- K231181: bright CT (2023), 0 descendants of its own
- K232487: Provecta 3D Prime and Provecta 3D Prime Ceph (2023), 0 descendants of its own

## Indications for use
ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric 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.

Source page: https://510kreport.com/device/K193139
Methodology: https://510kreport.com/methodology