# K193622: TRIOCLEAR System

- Pathway: 510(k) (Traditional)
- Applicant: Perfection Aligner System Hong Kong Limited
- Decided: Jul 6, 2021 after 558 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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163689: 3M Clear Tray Aligner, 3M Unitek Corporation (2017) Summary page 4.

## Most influential descendants
- K231884: TRIOCLEAR System (2023), 0 descendants of its own

## Indications for use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movement, it sequentially positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K193622
Methodology: https://510kreport.com/methodology