Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
510(k) K181167
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK181167 | Date2 Sep 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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
Overview
AI-generated summary, 18 Sep 2026
The Upcera Glaze Paste, Glaze Powder, and Glaze Liquid are dental materials designed for the application of ceramic glazes in restorative and aesthetic dental procedures. These products are used to create a protective, smooth, and visually appealing surface on dental restorations, such as crowns, bridges, and veneers, ensuring durability and esthetic integration with natural teeth.
Supplied as paste, powder, and liquid formulations, these materials are intended for use in dental laboratories and clinical settings by trained professionals. The products are classified under the dental category and are intended for single-use applications, requiring proper mixing and application techniques. Authorized under FDA 510K and MDR compliance, they adhere to regulatory standards for dental materials, ensuring safety and efficacy in restorative dentistry.
Other devices from Liaoning Upcera Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What are the three forms of Upcera Glaze available, and how are they used together in dental procedures?
The Upcera Glaze comes in three forms: Paste, Powder, and Liquid. These are designed to be mixed together to create a ceramic glaze for dental restorations. The paste and powder are combined with the liquid to form a smooth, workable mixture that is applied to crowns, bridges, or veneers before firing in a dental laboratory. This process ensures a durable, aesthetically pleasing finish that blends with natural teeth.
Are these glazes meant for use in dental labs or directly in patient treatments, and who should apply them?
The Upcera Glaze Paste, Powder, and Liquid are intended for use in both dental laboratories and clinical settings, but they must be applied by trained dental professionals. The materials require proper mixing and application techniques, typically performed by dental technicians in labs or dentists in offices, to achieve the desired ceramic finish on restorations like crowns or veneers.
How are these glazes supplied, and do they require special handling or storage conditions?
The Upcera Glaze products are supplied as separate components—paste, powder, and liquid—requiring mixing before use. Since they are intended for single-use applications, proper storage in a clean, dry environment is recommended to maintain their integrity. The manufacturer’s instructions should be followed for optimal shelf life and handling, though specific storage conditions (e.g., temperature) are not detailed in the provided data.
What regulatory pathways have these glazes gone through, and what does that mean for safety and compliance?
The Upcera Glaze products have been authorized through FDA 510(k) clearance and MDR compliance, meaning they meet regulatory standards for dental materials in the U.S. and EU markets. The FDA’s Traditional 510(k) pathway (with a decision code of *SESE*—Substantially Equivalent) confirms they are as safe and effective as legally marketed predecessors. This ensures they are suitable for restorative dentistry applications while adhering to strict manufacturing and performance guidelines.