# K242929: Fas Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Xplora 3D Europe S.L
- Decided: Dec 20, 2024 after 87 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- 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 K780619 (1978). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222418: Nuvola, Gruppo Europeo Ortodonzia Srl (2022) Summary page 5.

## Indications for use
Fas Aligner System is intended for the orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K242929
Methodology: https://510kreport.com/methodology