# K242892: Cristaline Aligners Z FLX

- Pathway: 510(k) (Traditional)
- Applicant: Cristaline Aligners GmbH
- Decided: Dec 19, 2024 after 87 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: 8 generations back to K780619 (1978). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX, Blue Sky Bio, LLC (2024) Summary page 5.

## Indications for use
Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.

Source page: https://510kreport.com/device/K242892
Methodology: https://510kreport.com/methodology