(29 days)
BruxZir® Esthetic 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® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
The provided text describes the regulatory submission for a dental material (BruxZir® Esthetic NOW) and its comparison to a predicate device. It includes performance data, but NOT information typically associated with AI/ML device studies, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, the response will focus on the available information regarding acceptance criteria and the study that proves the device meets those criteria, highlighting the lack of AI/ML-specific details where applicable.
Here's a summary of the acceptance criteria and study findings based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (BruxZir® Esthetic NOW) |
|---|---|
| Flexural Strength: >800 MPa (Type II Class 5 per ISO 6872:2024) | Average flexural strength of worst-case shades was above the minimum threshold of 800 MPa (meeting ISO 6872:2024 for Type II Class 5 ceramic). |
| 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.