# K232487: Provecta 3D Prime and Provecta 3D Prime Ceph

- Pathway: 510(k) (Special)
- Applicant: Durr Dental SE
- Decided: Sep 14, 2023 after 28 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: 1 generation back to K193139 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193139: ProVecta 3D Prime Ceph, Durr Dental SE (2020) Summary page 5.

## Indications for use
ProVecta 3D Prime and ProVecta 3D Prime Ceph are computed tomography x-ray units intended to generate 3D, panoramic and cephalometric (ProVecta 3D Prime Ceph Model) X-ray images in dental radiography for adult and pediatric patients. They provide diagnostic details of the maxillofacial areas for a dental treatment. The devices are operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

Source page: https://510kreport.com/device/K232487
Methodology: https://510kreport.com/methodology