# K220689: Vatech Clismile

- Pathway: 510(k) (Traditional)
- Applicant: Rayence Co., Ltd.
- Decided: May 6, 2022 after 58 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- 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 K852179 (1985). 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)
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 4.

## Indications for use
Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Source page: https://510kreport.com/device/K220689
Methodology: https://510kreport.com/methodology