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Xavex G100 is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations. It is a partially sintered yttria stabilized zirconium oxide powder that has to be machined with the CAD/CAM technique to its required shape and then sintered to full density. Xavex G100 is recommended for manufacturing substructures of single tooth and bridgework with up to two pontics, which can be used in the anterior as well as in the posterior tooth region.

Xavex G100 is a dental ceramic that is composed of partially sintered yttria (yttrium oxide) stabilized zirconium oxide. Xavex G100 is designed for manufacturing substructures of all-ceramic dental appliances for the sole use of particular patients. It has to be machined with the CAD/CAM technique and then sintered to its full density. Xavex G100 is designed for use as single tooth or bridgeworks with up to two pontics in the anterior as well as the posterior teeth region. Xavex G100 is biocompatible and insoluble in water. In addition, the strength of densely sintered Zirconium oxide is extremely high and makes delicate and filigree framework shaping possible. This, together with the white color of the zirconium oxide offers the basis for aesthetically pleasing, safe and effective dental restorations. Xavex G100 substructures can be veneered with suitable dental porcelains with the layering technique. Xavex G100 meets all applicable requirements of the standard ISO 6872: 1997 "Dental ceramic". The partially sintered Xavex G100 blanks will be offered as disks with a diameter of 100 mm and 5 different thicknesses: Xavex G100-25 with a thickness of 25 mm Xavex G100-20 with a thickness of 20 mm Xavex G100-18 with a thickness of 18 mm Xavex G100-14 with a thickness of 14 mm Xavex G100-10 with a thickness of 10 mm

I am sorry, but the provided text from the "Premarket Notification 510 (k) Xavex G100" does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document describes the device (Xavex G100), its intended use, and the regulatory approval process (510(k) summary and FDA letter of substantial equivalence). It states that the device "meets all applicable requirements of the standard ISO 6872: 1997 'Dental ceramic'," but it does not detail those requirements or present a study proving compliance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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