# K221537: Nightwear Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Smylio, Inc.
- Decided: Apr 5, 2023 after 313 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: 4 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200908: iSMILE, 3D Diagnostix, Inc. (2020) Summary page 4.

## Indications for use
Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K221537
Methodology: https://510kreport.com/methodology