# K160666: Dentiq3D

- Pathway: 510(k) (Traditional)
- Applicant: 3D Industrial Imaging Co., Ltd.
- Decided: Oct 5, 2016 after 210 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K954874 (1996). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152746: Ez3D Plus, Ewoosoft Co., Ltd. (2016) Summary page 5.

## Indications for use
Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Source page: https://510kreport.com/device/K160666
Methodology: https://510kreport.com/methodology