# K210820: EAGLE EDGE AXR90 and AXR120

- Pathway: 510(k) (Abbreviated)
- Applicant: Alliage S/A Industrias Medico Odontológica
- Decided: Aug 10, 2021 after 144 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: 9 generations back to K973598 (1997). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray, Panoramic Corp. (2016) Summary page 4.

## Most influential descendants
- K223816: Dental CT Scanner AXR (2023), 0 descendants of its own

## Indications for use
The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units 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/K210820
Methodology: https://510kreport.com/methodology