# K223454: Custom-made Invisible Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Yinchili Medical Technology Co., Ltd.
- Decided: Apr 17, 2023 after 152 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203624: Custom-made Invisible Aligners, Zhejiang Yinchili Medical Technology Co., Ltd. (2022) Summary page 4.

## Indications for use
The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K223454
Methodology: https://510kreport.com/methodology