ARENA Star, Galaxy Star

ARENA Star and Galaxy Star are non-sterile zirconia blocks used to manufacture dental restorations such as artificial teeth, crowns, facings, and veneers. The blocks are processed through CAD/CAM systems in dental laboratories or by dental professionals, then milled and sintered to create the final prosthesis.

The subject device is colored zirconia (ZrO2) discs with available thicknesses of 10–30 mm and 17 shade options (A0–D4). It maintains a post-sintering density of 6.00 g/cm³, flexural strength >800 MPa per ISO 6872:2015 Type II Class 5, and sintering temperature of 1500 ± 50 °C. The chemical composition (ZrO2 with yttrium oxide, erbium oxide, ferric oxide, and manganese oxide additives) and all physical properties are identical to the predicate device.

ISO 6872 (Dentistry - Ceramic Materials) for performance testing including visual inspection, dimensions, packaging, uniformity, chemical solubility, flexural strength, and linear thermal expansion. ISO 10993-5:2009 for cytotoxicity, ISO 10993-10:2010 for intracutaneous reactivity and sensitization, and ISO 10993-11:2017 for acute systematic toxicity.

The subject device differs from the predicate only by the addition of shade color options; the chemical composition, mechanical properties, density, sintering temperature, and all technological characteristics are identical. Since shade variation does not affect the fundamental scientific functionality or safety of the zirconia block material, and both devices meet the same ISO 6872 Class 5 dental ceramic specifications with equivalent biocompatibility, the devices are substantially equivalent.