# K183676: DentiqAir

- Pathway: 510(k) (Traditional)
- Applicant: 3D Industrial Imaging Co., Ltd.
- Decided: Dec 19, 2019 after 356 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: 7 generations back to K924630 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110430: Dolphin Imaging, Patterson Dental Supply, Inc. (2011) Summary page 5.
- K133320: Sicat Function, Sicat GmbH & Co. KG (2014) Summary page 5.

## Indications for use
DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems.

Source page: https://510kreport.com/device/K183676
Methodology: https://510kreport.com/methodology