# K223029: Perfit CL

- Pathway: 510(k) (Traditional)
- Applicant: Vatech Mcis Co., Ltd.
- Decided: Jun 20, 2023 after 264 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K123680 (2013). 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)
- K173769: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid, Dmax Co., Ltd. (2018) Summary page 4.

## Indications for use
Perfit CL can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Source page: https://510kreport.com/device/K223029
Methodology: https://510kreport.com/methodology