(70 days)
Obsidian® NOW is used to fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology. The block is processed through dental laboratories or by dental professionals.
Obsidian® NOW is a fully crystallized lithium disilicate glass-ceramic block that can be milled to produce dental restorations using CAD/CAM technology. The block is intended to be used for fabricating monolithic restorations such as full contour crowns without requiring any additional crystallization prior to placement. The milling block is offered in the commonly used VITA® Classical and Chromascop® Bleach shades.
Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Material Properties | |
| Flexural Strength: ≥300 MPa (ISO 6872:2015/Amd 1:2018, Type II Class 3) | Average flexural strength met the acceptance criteria of 300 MPa (Type II, Class 3) |
| Chemical Solubility: |
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.