# K240501: Spark™ Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corporation
- Decided: Oct 11, 2024 after 233 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)
- K203737: Spark Clear Aligner System, Ormco Corporation (2021) Summary page 5.
- K203688: Clear Aligner, Wuxi EA Medical Instruments Technologies Limited. (2021) Summary page 5.

## Most influential descendants
- K250487: SparkTM Clear Aligner System (2025), 0 descendants of its own

## Indications for use
The SparkTM Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K240501
Methodology: https://510kreport.com/methodology