Search Results

Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Vita In-Ceram YZ® Cubes for Cerec®." This document confirms the device's substantial equivalence to a predicate device and outlines general regulatory requirements.

However, the document does NOT contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or training sets. Therefore, I cannot extract the requested information.

The 510(k) letter is a regulatory approval document, not a scientific study report. It states that the device is "substantially equivalent" to an existing legally marketed device, which typically means it has similar intended use, technological characteristics, and performs as safely and effectively as the predicate device. The detailed performance data and study methodologies you're asking for would usually be part of the submission package that led to this approval, but they are not included in this letter.

Ask a specific question about this device