# K250487: SparkTM Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corporation
- Decided: Feb 20, 2025 after 1 day
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223517: Clear Aligner, Wuxi EA Medical Instruments Technologies Limited. (2023) Summary page 6.
- K240501: Spark™ Clear Aligner System, Ormco Corporation (2024) Summary page 6.

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

Source page: https://510kreport.com/device/K250487
Methodology: https://510kreport.com/methodology