# K192767: Clear Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Royal Dental Lab
- Decided: Jan 8, 2020 after 100 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: 1 generation back to K173784 (2018). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173784: Smylic Invisible Clear Aligners, Smylio, Inc. (2018) Summary page 4.

## Most influential descendants
- K210373: Clear Aligners (2021), 1 descendant of its own
- K222918: DentCare Aligners (2022), 0 descendants of its own

## Indications for use
This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Source page: https://510kreport.com/device/K192767
Methodology: https://510kreport.com/methodology