# K191902: Razor, Everest, U&C Liquid

- Pathway: 510(k) (Traditional)
- Applicant: U&C International Co., Ltd.
- Decided: Oct 11, 2019 after 87 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: 3 generations back to K060104 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143330: BruxZir Anterior, Prismatik Dentalcraft, Inc. (2014) Summary page 4.
- K143090: Luminesse Pre-Sintered Zirconia Coloring Liquid, Talladium, Inc. (2015) Summary page 4.

## Indications for use
The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. U&C Liquid 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/K191902
Methodology: https://510kreport.com/methodology