# K232887: Invisalign Palatal Expander System

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Dec 15, 2023 after 88 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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 7.
- K935154: Dentaurum Expansion Screws, Dentauraum, Inc. (1994) Summary page 7.

## Most influential descendants
- K252931: Invisalign® Palatal Expander System (2025), 0 descendants of its own

## Indications for use
The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

Source page: https://510kreport.com/device/K232887
Methodology: https://510kreport.com/methodology