(282 days)
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials. The Dental Zirconia Blocks are provided as non-sterile.
The provided text describes the 510(k) summary for the "Dental Zirconia Blocks" device (K192262). This document focuses on demonstrating substantial equivalence to a predicate device, rather than performing a clinical study with acceptance criteria for a novel AI/software medical device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details for an AI/software device cannot be extracted from this document.
This document describes a traditional medical device (dental zirconia blocks) and the testing performed is for physical and chemical properties, as well as biocompatibility, against established international standards.
For completeness, here's a summary of the testing performed and conclusions drawn from the provided text, adapted as much as possible to the prompt's structure, but it's important to reiterate that this is not an AI/software device study.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various ISO standards. The document states that the proposed device "met all design specifications" and "complies with" these standards. The "acceptance criteria" are implied by the requirements of these standards.
| Acceptance Criteria (from referenced ISO standards) | Reported Device Performance (from text) |
|---|---|
| ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials | Complies with ISO 6872 |
| Flexural strength > 800MPa | > 800MPa |
| 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.