DenMat Multilayered Zirconia Disc

The DenMat Multilayered Zirconia Disc is a dental material made of yttria-stabilized tetragonal zirconia (Y-TZP) used to fabricate anterior and posterior dental restorations (crowns and bridges) using CAD/CAM or manual machining. The discs are processed through dental laboratories or by dental professionals and must be milled and sintered to create final dental prosthetics.

The device is composed of zirconia ceramics (ZrO₂+HfO₂+Y₂O₃ ≥98%) meeting ISO 6872 Type II, Class 5 specifications. It achieves flexural strength >800 MPa and fracture toughness >5.0 MPa√m, enabling use in restorations with four or more units. Available in four disc sizes (98.5 mm diameter, 14–25 mm thickness) with sintered density ≥6.0 g/cm³ and coefficient of thermal expansion of 10.39±0.34 (×10⁻⁶ K⁻¹).

ISO 6872:2024 (dental ceramics), ISO 13356:2015 (zirconia density), ISO 10993-1:2018 (biocompatibility evaluation), ISO 7405 (biocompatibility of dental devices), ASTM E831 (thermal expansion), ISO 18756/ASTM C1421 (fracture toughness).

The device shares the same indications for use (anterior and posterior restorations via CAD/CAM/manual machines) and intended user (dental laboratories and professionals) as the predicate UPCERA Gradual Dental Zirconia Blank. Both devices have substantially equivalent zirconia composition, meet identical ISO 6872 Class 5 performance requirements, and demonstrate similar mechanical properties (flexural strength, fracture toughness, density). Performance testing confirms the subject device meets or exceeds all applicable standards, and biocompatibility testing shows no adverse reactions, establishing that differences are minor and raise no new safety concerns.