(30 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 highly 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, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.
The provided text describes the submission for a dental device, BruxZir® Esthetic (K240882), and compares it to a predicate device (K213425). The focus of the submission is to demonstrate substantial equivalence through non-clinical testing. This is not a submission for an AI/ML powered device, and therefore, many of the requested elements related to AI/ML specific studies (e.g., MRMC studies, standalone AI performance, training set details, ground truth establishment for AI models) are not applicable.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning the physical and chemical properties of the dental material.
Here's a breakdown of the requested information based on the provided text, while noting the inapplicability of AI/ML specific questions:
Device: BruxZir® Esthetic (K240882)
Device Type: Zirconia milling blanks for dental restorations. This is a material, not an AI/ML powered device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flexural Strength | >800 MPa (per ISO 6872:2015/Amd 1:2018, Type II Class 5) | Met the criteria (>800 MPa) |
| Visual Shade Evaluation | Grade of "Pass" for Visual Shade Match for all shades. | Met the criteria |
| Color Consistency | ΔE calculation needs to be less than 2.00 between samples measured. | Met the criteria |
| Translucency | Within 1% of the equivalent BruxZir Anterior-16 shade at 700nm. | Met the criteria |
| Coefficient of Thermal Expansion (CTE) | Between 10-11 x 10^-6 /°C, and standard deviation of CTE no greater than 0.5 x 10^-6 /°C (per ISO 6872:2015/Amd 1:2018). | Met the criteria (Reported range: 10-11 x 10^-6 /°C; implies standard deviation also met based on compliance statement) |
| 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.