# K220287: Invisalign System

- Pathway: 510(k) (Special)
- Applicant: Align Technology, Inc.
- Decided: Apr 7, 2022 after 65 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K780619 (1978). 5 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181739: Invisalign System with Mandibular Advancement Feature, Align Technology, Inc. (2018) Summary page 5.

## Most influential descendants
- K232233: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (2023), 3 descendants of its own
- K241412: Invisalign System (2024), 2 descendants of its own
- K222418: Nuvola (2022), 2 descendants of its own
- K252380: Invisalign System (2025), 1 descendant of its own
- K232074: Serafin® (2024), 1 descendant of its own

## Recalls of this device
- Dec 5, 2022 · Class II · Z-1017-2023: 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.

## Indications for use
The Invisalign System is intended for the orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K220287
Methodology: https://510kreport.com/methodology