# K222918: DentCare Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Dentcare Dental Lab Pvt, Ltd.
- Decided: Nov 25, 2022 after 60 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 K173784 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210373: Clear Aligners, Shenzhen Yinuo Dental Technology Co.Ltd (2021) Summary page 4.

## Indications for use
DentCare Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.

Source page: https://510kreport.com/device/K222918
Methodology: https://510kreport.com/methodology