# K200908: iSMILE

- Pathway: 510(k) (Traditional)
- Applicant: 3D Diagnostix, Inc.
- Decided: Dec 22, 2020 after 260 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: 3 generations back to K780619 (1978). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081960: Invisalign System, Align Technology (2008) Summary page 4.

## Most influential descendants
- K221537: Nightwear Aligners (2023), 0 descendants of its own
- K222308: Al Smile Aligner (2022), 0 descendants of its own

## Indications for use
iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K200908
Methodology: https://510kreport.com/methodology