# K143630: Invisalign System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Nov 18, 2015 after 331 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: 3 generations back to K780619 (1978). 3 ancestors in all.
41 later devices descend from it; 5 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081960: Invisalign System, Align Technology (2008) Summary page 4.

## Most influential descendants
- K181739: Invisalign System with Mandibular Advancement Feature (2018), 18 descendants of its own
- K220287: Invisalign System (2022), 13 descendants of its own
- K203737: Spark Clear Aligner System (2021), 10 descendants of its own
- K212660: Smylio Invisible Clear Aligners (2021), 7 descendants of its own
- K182826: Ormco Spark Aligner System (2018), 6 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/K143630
Methodology: https://510kreport.com/methodology