(19 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.
BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant 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® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.
The provided document is a 510(k) summary for the medical device BruxZir® Radiant. It outlines the acceptance criteria and the studies conducted to demonstrate that the device meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flexural Strength: >500 MPa per ISO 6872:2015/Amd 1:2018 (Type II Class 4) | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, including Flexural Strength >500 MPa. |
| Translucency at 700nm: | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating that the translucency of each formulation was higher than the specified values: |
| * White: >59% | * White: >59% |
| * Brite: >65% | * Brite: >65% |
| * 100: >57% | * 100: >57% |
| * 200: >57% | * 200: >57% |
| * 300: >57% | * 300: >57% |
| * 400: >57% | * 400: >57% |
| Visual Shade Match: Grade of "Pass" for all shades | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, implying a "Pass" grade for Visual Shade Match for all shades. |
| Color Consistency: ΔE |
§ 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.