# K213579: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

- Pathway: 510(k) (Traditional)
- Applicant: Fona S.R.L
- Decided: Mar 2, 2022 after 112 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: 8 generations back to K973642 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150217: Orthophos SL, Sirona Dental Systems GmbH (2015) Summary page 4.

## Indications for use
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Source page: https://510kreport.com/device/K213579
Methodology: https://510kreport.com/methodology