# K202792: BRIUS Clear Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Brius Technologies, Inc.
- Decided: Jan 22, 2021 after 122 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.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191838: Clearform Aligners, Motor City Lab Works (2020) Summary page 4.

## Most influential descendants
- K233152: GENIOVA aligners (2024), 0 descendants of its own
- K220835: Arkligners (2022), 0 descendants of its own

## Indications for use
BRIUS Clear Aligners 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/K202792
Methodology: https://510kreport.com/methodology