# K222894: Invisalign System, Pre-Formed Attachment System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Dec 22, 2022 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K252870: Invisalign Specifix Attachment System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K222894
Methodology: https://510kreport.com/methodology