# K212680: LuxCreo Clear Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: LuxCreo, Inc.
- Decided: May 31, 2022 after 280 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: 7 generations back to K780619 (1978). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192596: ULab Systems Dental Aligner Kit, Ulab Systems, Inc. (2020) Summary page 5.
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 5.

## Most influential descendants
- K250739: Primeprint Direct Aligner (2025), 0 descendants of its own
- K251415: Additively Manufactured Aligner Resin (2025), 0 descendants of its own
- K250343: LuxCreo Clear Aligner System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K212680
Methodology: https://510kreport.com/methodology