# K191990: OSW Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Osw Manufacturing, LLC
- Decided: Aug 23, 2019 after 29 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: 5 generations back to K780619 (1978). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171674: Angel Align System, Smile Development Corp (2018) Summary page 4.

## Most influential descendants
- K200214: 3D Predict (2020), 0 descendants of its own

## Indications for use
OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K191990
Methodology: https://510kreport.com/methodology