# K250839: Dental X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Boen Zhongding Medical Technology Co., Ltd.
- Decided: Jun 11, 2026 after 448 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: 10 generations back to K973598 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212254: DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa), Hdx Will Corp. (2021) Summary page 5.
- K223058: EzRay Air 2 Wall (Model: VEX-S350W), VATECH Co., Ltd. (2022) Summary page 5.

## Indications for use
The Dental X-ray System is a digital, extra-oral imaging system with panoramic, cephalometric, and tomographic capabilities, designed to: a. Produce orthopantomographic images of the maxillofacial region. b. Generate radiographs of the jaws, parts of the skull, and carpus for cephalometric examination, if equipped with a CEPH arm. c. Produce tomographic images of the head, including the ear, nose, and throat (ENT), the dentomaxillofacial complex, teeth, mandible, maxilla, temporomandibular joint (TMJ), and other areas of the human skull and neck, including sections of the cervical spine, for diagnostic support. If equipped with a Dental X-ray Unit, The Dental X-ray Unit is an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors (intra-oral image receptors is not included in our Dental X-ray System). The device is operated and used by physicians, dentists, radiologic technologists, and other qualified professionals.

Source page: https://510kreport.com/device/K250839
Methodology: https://510kreport.com/methodology