Razor Everest U&C Liquid
510(k) K191902
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191902 | Date11 Oct 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIH
- FDA applicant
- U&C International Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Razor Everest U&C Liquid is a dental instrument system designed for dental technicians to construct custom all-ceramic restorations for both anterior and posterior teeth. This system includes tools and materials for shaping and finishing zirconium dioxide-based restorations, aligning with the classification of Powder, Porcelain (product code EIH).
The system is intended for use in dental laboratories, where dental technicians apply the Razor and Everest tools alongside U&C Liquid as an accessory. Supplied as a reusable set, the device is regulated under FDA 510(k) clearance (K191902) and falls under Class II – Special Controls. No sterility or single-use specifications are noted in the data.
Other devices from U&C International Co., Ltd
Questions
AI-generated answers, 19 Sep 2026
What is the Razor Everest U&C Liquid system specifically designed for in a dental lab environment?
The Razor Everest U&C Liquid system is designed exclusively for dental technicians to construct custom all-ceramic restorations using zirconium dioxide-based materials. It includes tools for shaping and finishing both anterior (front) and posterior (back) teeth restorations, making it ideal for precision work in dental laboratories.
Is the Razor Everest U&C Liquid system reusable or single-use, and how is it supplied?
The Razor Everest U&C Liquid system is supplied as a reusable set of tools, meaning it is intended for repeated use in dental laboratories. The system includes the Razor and Everest tools alongside U&C Liquid as an accessory, with no indication of single-use requirements.
How is the Razor Everest U&C Liquid system regulated, and what does that mean for dental labs?
The system is regulated under the FDA’s 510(k) clearance process (K191902) and classified as Class II with Special Controls. This means it has undergone a review to demonstrate substantial equivalence to a predicate device and meets additional safety and performance standards, ensuring it is safe and effective for its intended use in dental laboratories.
What type of materials does the Razor Everest U&C Liquid system work with, and where is it primarily used?
The system is designed to work with zirconium dioxide-based materials for constructing all-ceramic restorations. It is primarily used in dental laboratories by technicians to shape and finish custom restorations for both anterior and posterior teeth, ensuring precise and durable dental prosthetics.