# K212254: DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Oct 19, 2021 after 92 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 K973598 (1997). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160140: DENTRIa    series, Hdx Will Corp. (2016) Summary page 5.

## Most influential descendants
- K250839: Dental X-ray System (2026), 0 descendants of its own

## Indications for use
The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K212254
Methodology: https://510kreport.com/methodology