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510(k) Data Aggregation
(59 days)
Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, and provided non-sterile.
This document describes the premarket notification (510(k)) for "Zirconia Dental Ceramics." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove clinical performance or a specific diagnostic accuracy. Therefore, the questions related to AI/ML device performance (e.g., acceptance criteria for accuracy, MRMC studies, ground truth establishment for training/test sets, expert adjudication) are largely not applicable to this type of medical device submission (dental ceramics).
The acceptance criteria and "study" described in this document are focused on non-clinical performance testing to demonstrate that the physical, chemical, and biological properties of the Zirconia Dental Ceramics conform to established standards for dental ceramic materials.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
Acceptance Criteria and Device Performance for Zirconia Dental Ceramics
The acceptance criteria for this device are based on demonstrating compliance with the international standard ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 7405:2018 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry" for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ISO 6872:2015, etc.) | Reported Device Performance (Zirconia Dental Ceramics) | Judgment |
|---|---|---|---|
| Uniformity | Uniform (Expected for ceramic materials) | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials (Expected) | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq.g⁻¹ |
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(127 days)
Zirconia Dental Ceramics are intended for crowns, multiunit bridges. Application includes both anterior and posterior bridges.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Zirconia Dental Ceramics." It primarily addresses the substantial equivalence determination for the device and its indications for use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
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