# K211427: CREOKORREKT Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Creodent Prosthetics, Ltd.
- Decided: Oct 13, 2022 after 524 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192846: Argen Clear Aligner, Argen Clear Aligner Premium, Argen Corporation (2020) Summary page 4.

## Indications for use
The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K211427
Methodology: https://510kreport.com/methodology