Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)

Dental Lithium Disilicate Glass Ceramic is a ceramic material supplied in cuboid and cylinder forms for fabrication of full ceramic dental restorations including crowns, inlays, onlays, veneers, and 3-unit anterior bridges using CAD/CAM and hot pressing techniques. It is composed of SiO₂, Li₂O, K₂O, P₂O₅, Al₂O₃, ZrO₂ and other oxides with inorganic pigments, and is provided non-sterile as a single-use device.

The proposed device matches the predicate in all material composition, design form, color options (HT, ML-HT, LT, ML-LT, MT, MO, HO translucencies and shades), crystallization state (cuboid partially crystallized; cylinder fully crystallized), and performance specifications including flexural strength (≥300 MPa), glass transition temperature (495±20°C), linear thermal expansion coefficient (9.8±0.5)×10⁻⁶K⁻¹, chemical solubility (<100 μg/cm²), and radioactivity limits. Both conform to ISO 6872:2015 Type II, Class 3.

ISO 6872:2015 (Dentistry - Ceramic materials), ISO 7405:2018 (Biocompatibility evaluation), ISO 10993-3, 10993-5, 10993-6, 10993-10, 10993-11, and 10993-23 (Biological evaluation of medical devices for genotoxicity, cytotoxicity, local effects, skin sensitization, systemic toxicity, and irritation).

The proposed device is substantially equivalent because it has identical indications for use as the predicate (full ceramic restorations via CAD/CAM and hot pressing), identical material composition and physical/mechanical properties, identical design forms and color options, identical crystallization states, and identical performance across all tested parameters including strength, thermal properties, chemical solubility, biocompatibility, and regulatory compliance. All material and design attributes are explicitly matched in the comparison table, demonstrating no meaningful differences in safety or effectiveness.