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This device is a ceramic-based material that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three-unit bridges) and processed by dental CAD/CAM.

The Eclipse Kiss Zirconia Dental Material is an integrated system of dental ceramic which support dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of dental restorations to meet the specific needs of individual dental patients. Each patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.

Eclipse Kiss Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges (up to maximum three unit bridges); which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.

Eclipse Kiss Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration to be produced.

This document is a 510(k) Premarket Notification for a dental material, Eclipse Kiss Zirconia. It primarily focuses on demonstrating substantial equivalence to a predicate device (DD Cubex2) rather than presenting a study proving the device meets general acceptance criteria.

Therefore, much of the requested information regarding specific acceptance criteria studies with human readers, training sets, test sets, and adjudication methods is not available in the provided text. This document is a regulatory submission for a material, not usually for a diagnostic AI device.

However, I can extract the available information regarding performance properties and the comparison study for demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For dental materials like Eclipse Kiss Zirconia, "acceptance criteria" are typically defined by performance properties that demonstrate the material's fitness for its intended use and similarity to established predicate devices. The document explicitly lists performance properties and compares them to the predicate device, DD Cubex2.

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