# K181739: Invisalign System with Mandibular Advancement Feature

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Oct 26, 2018 after 116 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: 4 generations back to K780619 (1978). 4 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143630: Invisalign System, Align Technology, Inc. (2015) Summary page 4.

## Most influential descendants
- K220287: Invisalign System (2022), 13 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K181739
Methodology: https://510kreport.com/methodology