# K183229: Argen Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Argen Corporation
- Decided: Jun 7, 2019 after 199 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: 2 generations back to K780619 (1978). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981095: Align System, Align Technology (1998) Summary page 4.

## Most influential descendants
- K192846: Argen Clear Aligner, Argen Clear Aligner Premium (2020), 2 descendants of its own
- K211427: CREOKORREKT Aligners (2022), 0 descendants of its own
- K173738: Archworx (2021), 0 descendants of its own

## Indications for use
The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K183229
Methodology: https://510kreport.com/methodology