CERABIEN MiLai

CERABIEN MiLai is a porcelain powder for dental restorations used to create all-ceramic prostheses by layering technique and baking onto ceramic frames of zirconia or lithium disilicate glass. It is intended for use in prosthetic dentistry to provide ceramic coverage over zirconia or lithium disilicate substructures.

The subject device has a slightly different coefficient of thermal expansion (CTE) compared to the primary predicate device but is designed for the same layering and baking application. The device was tested to support use on both zirconia and lithium disilicate substrates, with CTE ranging from 9.5×10⁻⁶/K to 11.0×10⁻⁶/K, whereas the primary predicate's CTE ranged from 9.5×10⁻⁶/K to 10.6/K.

Physical and mechanical testing was conducted according to ISO 6872:2015 and ISO 9693:2019. Thermal shocking testing was performed per ISO 9693:2019 to evaluate compatibility with different lithium disilicate substrates.

The subject device meets the same ISO 6872:2015 and ISO 9693:2019 standards as the primary predicate device. Although CTE differs slightly, thermal shocking testing confirmed the subject device performs adequately on both zirconia and lithium disilicate substrates. The indications for use are substantially equivalent, as both devices are applied using identical layering technique and baked onto ceramic frames, and nonclinical test results demonstrate the subject device is as safe, effective, and performs as well as the predicate.