Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

Smart Print Bio Vitality is a light-curable methacrylate-based resin designed for use in 3D printers to fabricate permanent dental restorations including crowns, veneers, inlays, onlays, artificial teeth, and full or partial dentures. The material is intended for professional dental use by clinicians in dental offices and laboratories.

Both the subject and predicate devices are photocurable acrylic resins processed through additive manufacturing using CAD/CAM technology and digital scanning. They share the same fundamental technological principles: light-curable acrylate formulations used with 3D printers relying on digital imaging, undergoing light curing before final trimming and finishing, and intended for fabricating permanent dental restorations. Differences are limited to variations in resin composition that do not alter intended use, technological principle, or safety and effectiveness.

Biocompatibility testing per ISO 10993-1 and ISO 7405; mechanical and material properties per ISO 10477 and ISO 4049; testing parameters included flexural strength, water sorption and solubility, radio-opacity, print accuracy/dimensional stability, color stability, material stability, and shelf-life validation.

The subject device is substantially equivalent to the predicate Digital Crown (K222623) because both are light-curable resins for fabricating permanent dental restorations using 3D printing and CAD/CAM workflows. The non-clinical testing demonstrates the subject device is as safe and effective as the predicate in biocompatibility, shelf-life, and performance metrics. Compositional differences do not alter the intended use, technological principle, or safety and effectiveness of the device.