# K191838: Clearform Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Motor City Lab Works
- Decided: Mar 20, 2020 after 255 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.
3 later devices descend from it; 1 cites 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)
- K180241: Orthocaps Twinaligner, Ortho Caps GmbH (2018) Summary page 4.

## Most influential descendants
- K202792: BRIUS Clear Aligners (2021), 2 descendants of its own
- K233152: GENIOVA aligners (2024), 0 descendants of its own
- K220835: Arkligners (2022), 0 descendants of its own

## Indications for use
ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.

Source page: https://510kreport.com/device/K191838
Methodology: https://510kreport.com/methodology