# K220726: K Clear

- Pathway: 510(k) (Traditional)
- Applicant: Kline Europe GmbH
- Decided: Mar 16, 2022 after 2 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212660: Smylio Invisible Clear Aligners, Smylio, Inc. (2021) Summary page 4.

## Most influential descendants
- K260527: FACE4D Aligner (2026), 0 descendants of its own

## Indications for use
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).

Source page: https://510kreport.com/device/K220726
Methodology: https://510kreport.com/methodology