# K222418: Nuvola

- Pathway: 510(k) (Traditional)
- Applicant: Gruppo Europeo Ortodonzia Srl
- Decided: Oct 7, 2022 after 58 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: 6 generations back to K780619 (1978). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220287: Invisalign System, Align Technology, Inc. (2022) Summary page 4.

## Most influential descendants
- K260722: SureSmile Aligner (ASSY500020) (2026), 0 descendants of its own
- K242929: Fas Aligner System (2024), 0 descendants of its own

## Indications for use
Nuvola® aligner is intended for the orthodontic treatment of malocclusion

Source page: https://510kreport.com/device/K222418
Methodology: https://510kreport.com/methodology