(134 days)
BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.
The provided text describes the regulatory clearance of a dental material, BruxZir® NOW, and its comparison to a predicate device, Perfit FS Dental Zirconia Fully Sintered Block. The information primarily focuses on demonstrating substantial equivalence rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.
However, I can extract the relevant performance data and acceptance criteria as described for the dental material itself. The document does not describe an AI/ML device, an MRMC study, or a standalone algorithm performance study. It's about a physical dental material.
Here's the information based on the provided text, interpreted for the dental material:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ISO/ASTM Standards) | BruxZir® NOW Performance |
|---|---|
| Flexural Strength: | >800 MPa |
| Type II Class 5 per ISO 6872:2015/Amd 1:2018 (>800 MPa) | |
| 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.