# K252931: Invisalign® Palatal Expander System

- Pathway: 510(k) (Special)
- Applicant: Align Technology, Inc.
- Decided: Oct 23, 2025 after 38 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: 7 generations back to K780619 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232887: Invisalign Palatal Expander System, Align Technology, Inc. (2023) Summary page 5.

## 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 teeth, palate) with primary, mixed, or permanent dentition and 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/K252931
Methodology: https://510kreport.com/methodology