# K192596: ULab Systems Dental Aligner Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ulab Systems, Inc.
- Decided: Feb 11, 2020 after 144 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). 9 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180241: Orthocaps Twinaligner, Ortho Caps GmbH (2018) Summary page 4.

## Most influential descendants
- K212680: LuxCreo Clear Aligner System (2022), 3 descendants of its own
- K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (2024), 1 descendant of its own
- K250739: Primeprint Direct Aligner (2025), 0 descendants of its own
- K251415: Additively Manufactured Aligner Resin (2025), 0 descendants of its own
- K242637: MEM Clear Aligner System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K192596
Methodology: https://510kreport.com/methodology