# K220835: Arkligners

- Pathway: 510(k) (Traditional)
- Applicant: Arklign Laboratories
- Decided: Aug 12, 2022 after 143 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: 8 generations back to K780619 (1978). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202792: BRIUS Clear Aligners, Brius Technologies, Inc. (2021) Summary page 5.

## Indications for use
Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

Source page: https://510kreport.com/device/K220835
Methodology: https://510kreport.com/methodology