# K081960: Invisalign System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology
- Decided: Dec 17, 2008 after 161 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: 2 generations back to K780619 (1978). 2 ancestors in all.
82 later devices descend from it; 9 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981095: Align System, Align Technology (1998) Summary page 3.

## Most influential descendants
- K143630: Invisalign System (2015), 41 descendants of its own
- K181739: Invisalign System with Mandibular Advancement Feature (2018), 18 descendants of its own
- K180241: Orthocaps Twinaligner (2018), 15 descendants of its own
- K220287: Invisalign System (2022), 13 descendants of its own
- K163689: 3M Clear Tray Aligner (2017), 13 descendants of its own

## Indications for use
The Invisalign® system is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K081960
Methodology: https://510kreport.com/methodology