# K191823: Clear-Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Cdb Corporation
- Decided: Dec 20, 2019 after 165 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: 4 generations back to K780619 (1978). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082556: Clearcorrect, Clearcorrect, Inc. (2009) Summary page 5.

## Most influential descendants
- K210613: HIT Clear Aligner (2021), 0 descendants of its own

## Indications for use
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K191823
Methodology: https://510kreport.com/methodology