# K203688: Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi EA Medical Instruments Technologies Limited.
- Decided: Oct 8, 2021 after 295 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: 5 generations back to K780619 (1978). 5 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K171674: Angel Align System, Smile Development Corp (2018) Summary page 4.

## Most influential descendants
- K240501: Spark™ Clear Aligner System (2024), 1 descendant of its own
- K223517: Clear Aligner (2023), 1 descendant of its own
- K250487: SparkTM Clear Aligner System (2025), 0 descendants of its own

## Indications for use
Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

Source page: https://510kreport.com/device/K203688
Methodology: https://510kreport.com/methodology