VITA YZ Multi Translucent

VITA YZ MULTI TRANSLUCENT is a zirconia-based porcelain powder for creating dental restorations including fully anatomical crowns, up to 4-unit bridges, veneered structures, inlays, onlays, and veneers in anterior and posterior tooth regions. It is designed for both fully and partially veneered single-tooth and multi-unit bridge substructures.

The subject device is a yttria-stabilized zirconia with reduced aluminum oxide content (0-1% vs. 1-3% in the primary predicate VITA YZ ST), providing improved translucency while maintaining mechanical strength. It differs from the secondary predicate (VITA Enamic), which is silica-based hybrid ceramic with polymer-infiltration, making it more flexible but less suitable for bridges.

EN ISO 6872:2019 (dental ceramic materials), DIN EN ISO 10993-1 and DIN EN ISO 7405 (biocompatibility). Testing included flexural strength (>800 MPa requirement), linear coefficient of thermal expansion (9.8-10.8 × 10⁻⁶ K⁻¹), chemical solubility (<100 µg/cm²), and uranium-238 radioactivity (≤1.0 Bq/g).

The subject device is substantially equivalent because it uses the same yttria-stabilized zirconia base material and manufacturing process as the primary predicate VITA YZ ST, with the only notable difference being lower aluminum oxide content to enhance translucency. All mechanical properties (flexural strength 922 ± 95 MPa), thermal expansion, chemical solubility, radioactivity, and biocompatibility meet or exceed the established standards. The restricted indications (4-unit bridges vs. multi-unit for the predicate) represent a narrower, not broader, intended use, maintaining safety and performance equivalence.