# K211510: uLab Systems Dental Aligner Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ulab Systems, Inc.
- Decided: Feb 24, 2022 after 286 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.
2 later devices descend from it; 1 cites it directly.
0 of 10 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). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K223141: STR8 Clear Aligner (2023), 1 descendant of its own
- K240038: Clear Moves Aligners (2024), 0 descendants of its own

## Indications for use
The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Source page: https://510kreport.com/device/K211510
Methodology: https://510kreport.com/methodology