Lucitone Digital Print Denture™ System

The Lucitone Digital Print Denture System is a methacrylate-based resin used with 3D additive printers and CAD/CAM technology to fabricate dental prostheses. It includes components for denture bases, teeth, bonding agents, and sealers, intended for full and partial dentures, implant overdentures, temporary dentures, try-in dentures, and provisional crowns and bridges.

The subject device uses methacrylate-based resin material identical to the primary predicate, is non-sterile with a 3-year shelf life, and demonstrates equivalent performance specifications: flexural strength ≥50 MPa, acceptable flexural modulus, water sorption <40 μg/mm³, and water solubility <7.5 μg/mm³. Biocompatibility meets ISO 10993 requirements in both devices.

ISO 10993 (biocompatibility testing). The document references flexural strength, flexural modulus, water sorption, and water solubility as test parameters but does not cite specific ASTM, ISO, or IEC standards for these mechanical tests.

The subject device shares the same fundamental technology, material composition, principles of operation, and intended use as the primary predicate (K231578). Performance testing for flexural strength, modulus, water sorption, and solubility all met predicate specifications. Minor expansions to indications for use (such as provisional crowns and bridges) do not raise new safety or efficacy questions because the underlying technology and biocompatibility profile remain unchanged from the cleared predicate.