# K231884: TRIOCLEAR System

- Pathway: 510(k) (Special)
- Applicant: Modern Dental Laboratory (Dg) Co., Ltd.
- Decided: Sep 1, 2023 after 66 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). 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)
- K193622: TRIOCLEAR System, Perfection Aligner System Hong Kong Limited (2021) Summary page 4.

## 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/K231884
Methodology: https://510kreport.com/methodology