(27 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
BruxZir® Esthetic blanks are zirconia milling blanks used for the production of esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white and pre-shaded varieties that can be easily adjusted to match the final shade.
This document describes the premarket notification (510(k)) for the BruxZir® Esthetic device, a dental ceramic material. The focus is on demonstrating its substantial equivalence to a predicate device, which usually involves performance testing against established standards.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| Flexural Strength: >800 MPa (ISO 6872:2015/Amd 1:2018, Type II, Class 5) | Average flexural strength of each worst-case block batch tested yielded results above 800 MPa minimum. |
| Density: >6.05 g/cm³ | >6.05 g/cm³ (Listed as "Same" with predicate, implying this was met) |
| Coefficient of Thermal Expansion (CTE/25-500°C): 10-11x10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C (ISO 6872:2015/Amd 1:2018) | Tests performed on high and low colorant extreme shades yielded CTE results within 10-11 x 10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C. |
| 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.