FDA 510(k) Class II cleared resin for use in 3D printing definitive individual and fixed full single crowns, definitive partial crowns in the front and posterior area, individual and fixed single veneers. It may also be used to produce artificial teeth for dentures and monolithic full and partial dentures.
Key Features
Ceramic Dominant (>50%, CDT code qualified)
Radiopaque material for clear visibility of restorations on radiographs
Smooth surface finish
Excellent marginal fit and wear resistance
Low water absorption and water solubility
Medical device listing number: D492222
FDA establishment #: 3014289665 (Production)
FDA product code: EBF, EBI, ELM