Dental ceramic

Intended purpose

This product is a pre-sintered, high-purity yttria-stabilized zirconia ceramic material supplied in block or puck form. It is intended to be used by qualified dental professionals in a dental laboratory setting for the computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific, fixed dental prostheses. These include crowns, bridges, inlays, onlays, and veneers that are to be permanently cemented or adhesively bonded to natural tooth structures. The zirconia material is processed using validated sintering protocols to produce durable, biocompatible restorations that restore both the function and aesthetics of the patient’s dentition. The final restorations are intended for long-term intraoral use and are not implant-supported. This device is classified as a custom-made, non-sterile medical device and is not intended to be reused or reprocessed.