# K223816: Dental CT Scanner AXR

- Pathway: 510(k) (Abbreviated)
- Applicant: Alliage S/A Industrias Medico Odontológica
- Decided: Apr 7, 2023 after 108 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: 10 generations back to K973598 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210820: EAGLE EDGE AXR90 and AXR120, Alliage S/A Industrias Medico Odontológica (2021) Summary page 4.

## Indications for use
The DENTAL CT SCANNER AXR is designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.

Source page: https://510kreport.com/device/K223816
Methodology: https://510kreport.com/methodology