Dental Zirconia Ceramic

Dental Zirconia Ceramic is a pre-shaded yttria-stabilized zirconia material used to fabricate dental restorations such as crowns, bridges, veneers, inlays, and onlays. The material is processed through CAD/CAM or manual milling machines by dental laboratories or professionals and is supplied non-sterile as a single-use device.

The subject device adds 12 new models (SHT-Plus, HT, ST, SHT, COLOR, ST-COLOR, Multilayer-3T, MC, FC, GC, EC, AT, and Multilayer) to the predicate device's existing models. Each new model has slightly different component compositions but maintains the same yttria-stabilized zirconia base material and meets the same ISO 6872 classification standards (Classes 4 and 5). The core material composition, color variations, dimensions, and single-use non-sterile format remain unchanged.

ISO 6872:2015/AMD 1:2018 (Dentistry: Ceramic Materials); ISO 13356:2015; ISO 7405:2018 (Biocompatibility); ISO 10993-1:2018 (Biological evaluation of medical devices); and FDA Guidance documents for biocompatibility.

The subject device maintains identical intended use, principle of operation, material composition, intended user population, and regulatory classification as the predicate device K222626. The modifications consist solely of adding new model variants with slightly different component concentrations, which do not alter the fundamental technological characteristics or raise different safety or effectiveness questions. Physical and mechanical properties of the new models were tested using the same ISO 6872 standard methods employed for the predicate device and demonstrated equivalent performance, confirming that the additions do not affect device safety or efficacy.