(84 days)
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (1025mm), color model (0M1/A1A4/B1B4/C1C4/D2~D4) and transparency model (T41/T45/T49/TR).
This document is a 510(k) Premarket Notification for a dental material, not a medical device involving AI or software. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like human reader improvement with AI assistance) is not applicable to this submission.
Here's a breakdown of why many of your questions cannot be answered from the provided text:
- No AI or Software: The device, "Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank," is a material for dental restorations. It does not involve any artificial intelligence, machine learning, or software components that would have performance metrics like sensitivity, specificity, or AUC, or require a ground truth established by experts.
- No Diagnostic or Interpretive Task: This device is a component used in manufacturing, not a diagnostic tool that interprets data or images.
- No Clinical Study for Performance Evaluation: The document explicitly states: "No clinical study is included in this submission." This means there is no human-in-the-loop performance evaluation or comparison against human experts.
However, I can extract information related to the performance testing that was conducted for this material:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here refer to the performance standards and biocompatibility tests for the material itself, not diagnostic accuracy. The reported device performance indicates conformance to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material Properties | ||
| Type and Class per | Type II Class 5 | Type II Class 5 |
| ISO 6872:2015 | ||
| Chemical Composition | ZrO2 ≥ 99.0%, Inorganic Pigment (Fe2O3, Er2O3) ≤ 1% | ZrO2 > 99.0%, Inorganic Pigment (Al2O3, SiO2, Fe2O3, Er2O3) |
§ 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.