# K233544: Mesheet

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Feb 22, 2024 after 111 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: 4 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222619: Ensmile, Ensmile Pvt, Ltd. (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K233544
Methodology: https://510kreport.com/methodology