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The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Ceramic Denture Zirconia Ceramics Block conforms to ISO 6872:2015 Dentistry: Ceramic Materials.

The Ceramic Denture Zirconia Ceramics Block are offered in four (4) different product families of shapes and a multitude of different sizes and are capable of being machined into complex dental shapes using modern machining methods.

The provided document is a 510(k) premarket notification for a medical device, specifically Ceramic Denture Zirconia Ceramics Block. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device rather than proving clinical efficacy through extensive studies that align with acceptance criteria typically seen in AI/ML device submissions.

Therefore, the information requested about acceptance criteria and study details (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training set details) is not applicable to this type of regulatory submission for this device.

Instead, the document details the device's physical and chemical properties and verifies its compliance with recognized international standards (ISO).

Here's the relevant information that can be extracted, formatted as requested where possible, but with the understanding that the "acceptance criteria" here refers to meeting established standards and physical properties:

1. Table of Acceptance Criteria and Reported Device Performance

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