# K262196: Invisalign System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Sep 25, 2026 after 88 days
- Product code: PNN (Orthodontic Software)
- 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: 9 generations back to K780619 (1978). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252380: Invisalign System, Align Technology, Inc. (2025) Summary page 6.

## Indications for use
The Invisalign System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

Source page: https://510kreport.com/device/K262196
Methodology: https://510kreport.com/methodology