# K160140: DENTRIa    series

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Sep 30, 2016 after 253 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 K973598 (1997). 20 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093590: Planmeca Promax 3D Max, Planmeca Oy (2010) Summary page 5.
- K142247: Rayscan a-Expert 3D, Ray Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own
- K212254: DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) (2021), 1 descendant of its own
- K181297: DENTIOIII series (DENTIOIII, DENTIOIII-S) (2018), 1 descendant of its own
- K263033: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (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 though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K160140
Methodology: https://510kreport.com/methodology