Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. Cad Series)
510(k) K141727
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) | NumberK141727 | Date18 Dec 2014 | 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- Withdrawn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 Dental Lithium Disilicate Glass Ceramic Block is a dental material classified as a ceramic block for dental restorations, designed for fabricating all-ceramic restorations such as veneers, inlays, onlays, and crowns. Its composition of lithium disilicate enables high-strength, esthetic dental restorations with superior translucency and durability, meeting the demands of modern restorative dentistry.
These blocks are supplied in multiple versions, including the UP.Press Series and UP.CAD Series, with specific model numbers such as MO 2-D (13-10) and HT A1-D (13-10). They are intended for use in dental laboratories and clinics, where they are milled or pressed into custom restorations using computer-aided design (CAD) or computer-aided manufacturing (CAM) systems. The blocks are non-sterile and must be sterilized or processed prior to use, adhering to standard dental sterilization protocols. Regulatory authorizations include FDA 510(k) clearance under the Traditional pathway and compliance with the EU Medical Device Regulation (MDR).
Other devices from Liaoning Upcera Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations can the Lithium Disilicate Glass Ceramic Block be used to create, and how does its composition contribute to their quality?
The Dental Lithium Disilicate Glass Ceramic Block is designed for fabricating high-strength, esthetic restorations such as veneers, inlays, onlays, and crowns. Its composition of lithium disilicate provides exceptional translucency and durability, making it ideal for modern restorative dentistry where both aesthetics and longevity are critical.
Are these blocks intended for single-use or can they be reused after processing? If reused, what sterilization steps are required?
The blocks are non-sterile and must be sterilized or processed prior to use, following standard dental sterilization protocols. They are not designed for single-use, but rather for milling or pressing into custom restorations in dental labs or clinics, where they can be reused after proper sterilization.
What are the key differences between the UP.Press Series and UP.CAD Series blocks, and how are they typically used in clinical settings?
The UP.Press Series and UP.CAD Series are both versions of the Lithium Disilicate Glass Ceramic Block, differentiated by their intended fabrication methods. The UP.Press Series is typically used in traditional pressing techniques, while the UP.CAD Series is designed for computer-aided milling or pressing (CAD/CAM systems). Both are supplied in specific model numbers (e.g., MO 2-D, HT A1-D) to accommodate different clinical workflows.
How should these blocks be stored, and what considerations should be taken into account to maintain their integrity before use?
While the exact storage instructions aren’t detailed in the data, dental ceramic blocks like these are generally stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are non-sterile and require processing before use, ensuring they remain free from contamination and physical damage is essential. Always follow the manufacturer’s guidelines for optimal handling.