# K200214: 3D Predict

- Pathway: 510(k) (Traditional)
- Applicant: 3D Smile USA, Inc.
- Decided: Feb 24, 2020 after 27 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191990: OSW Aligner System, Osw Manufacturing, LLC (2019) Summary page 3.
- K180241: Orthocaps Twinaligner, Ortho Caps GmbH (2018) Summary page 4.

## Indications for use
3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K200214
Methodology: https://510kreport.com/methodology