# K181297: DENTIOIII series (DENTIOIII, DENTIOIII-S)

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Nov 21, 2018 after 189 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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). 28 ancestors in all.
1 later device descends from it; 1 cites 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)
- K142058: Rayscan a-Expert, Ray Co., Ltd. (2015) Summary page 5.
- K992385: Orthopantomograph OP100D, Instrumentarium Corp. (1999) Summary page 5.
- K160140: DENTRIa    series, Hdx Will Corp. (2016) Summary page 5.

## Most influential descendants
- K201382: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (2020), 0 descendants of its own

## Indications for use
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists

Source page: https://510kreport.com/device/K181297
Methodology: https://510kreport.com/methodology