Easy On Universal Glaze & Stain
by Doctus Global 510(k)
Active
510(k) K231264
Overview
Easy On Universal Glaze & Stain is a dental ceramic finishing system designed for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate. It consists of paste-type stains, glazes, and liquids to achieve precise surface characterization and optical effects.
The device is supplied as individual bottles and is intended for use by knowledgeable and trained dental personnel. It is applied as a finishing system to enhance the appearance of dental prostheses. The product is regulated under FDA 510(k) clearance with product code EIH and was reviewed by the Dental advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231264 | Date30 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Questions
What is Easy On Universal Glaze & Stain used for?
It is a dental ceramic finishing system designed for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate. It uses paste-type stains, glazes, and liquids to achieve precise surface characterization and optical effects.
How is the device supplied?
The device is supplied as individual bottles containing the necessary stains, glazes, and liquids required for application. It is intended for use by knowledgeable and trained dental personnel only.
Is this a single-use or reusable system?
The device is supplied as individual bottles, implying it is a multi-use system where portions can be applied as needed over multiple procedures, provided proper storage and handling are maintained according to manufacturer guidelines.
What materials is it compatible with?
It is specifically formulated for use on dental crown and bridge constructions made of zirconium dioxide or lithium disilicate, particularly those that are monolithic or minimally reduced.
What is the regulatory status of this device?
The device is regulated under FDA 510(k) clearance with product code EIH. It was reviewed by the Dental advisory committee and received a Substantially Equivalent decision, indicating it is legally marketed in the United States.