Glass Ceramic

Glass Ceramic is a dental material used to prepare veneers, inlays, onlays, crowns, and three-unit anterior bridges using hot press or CAD/CAM fabrication techniques. It is available in multiple shades and translucency levels, composed of silicon dioxide, lithium oxide, potassium oxide, phosphorus pentoxide, aluminum oxide and other oxides.

The subject device and predicate are both lithium disilicate glass-ceramics classified as Type II, Class 3 dental ceramics. Both are non-sterile, single-use, prescription devices available in rectangular, cylindrical, and customized shapes with partially or fully crystallized states. Key differences include slightly higher glass transition temperature (555±20°C vs. 495±20°C) and comparable linear thermal expansion coefficients.

ISO 6872 (Dentistry - Ceramic Materials), ISO 10993-1 (Biological evaluation), ISO 10993-3 (Genotoxicity), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Skin sensitization), ISO 10993-11 (Systemic toxicity), and ISO 10993-23 (Irritation).

Both devices have identical indications for use, same product code (EIH), same regulatory classification (Class II, 21 CFR 872.6660), and meet identical performance specifications per ISO 6872 for Type II, Class 3 materials. The glass transition temperature difference does not raise safety or effectiveness concerns as it complies with FDA consensus standards. Nonclinical testing demonstrates the subject device is as safe and effective as the predicate device.