# K222619: Ensmile

- Pathway: 510(k) (Traditional)
- Applicant: Ensmile Pvt, Ltd.
- Decided: Mar 16, 2023 after 198 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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
- K233544: Mesheet (2024), 0 descendants of its own

## Indications for use
Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Source page: https://510kreport.com/device/K222619
Methodology: https://510kreport.com/methodology