FP3D

FP3D is a dual-cure resin designed for 3D printing flexible partial dentures in dental laboratories using Carbon 3D printers. It is used within a CAD/CAM digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure equipment to fabricate removable partial dentures for partially edentulous patients.

FP3D is a flexible removal partial denture resin composed of part A acrylate resin and part B diamine-based resin at a 10:1 ratio, manufactured via additive (3D printing) technology. Unlike the predicate KeyDenture Base (a photopolymer), FP3D is a dual-cure resin. Both use light-curable acrylate resins and identical additive manufacturing processes; the increased flexibility of FP3D is intended for comfort and patient experience without changing the intended use.

ISO 20795-1:2013 (Dentistry — Base polymers for denture bases) for physical properties including color stability, ultimate flexural strength, flexural modulus, water sorption, and water solubility. ASTM D348 (tensile properties) and ASTM D790 (flexural modulus) for additional testing. ISO 10993 (Biocompatibility) confirming the device meets requirements for permanent (>30 days) mucosal contact.

FP3D has an identical intended use and similar indications for use as the predicate KeyDenture Base—both are 3D-fabricated denture resins for CAD/CAM denture base fabrication. Although FP3D is dual-cure rather than photopolymer-based and emphasizes flexibility for partial dentures (versus the predicate's full or partial dentures), these material and design differences do not raise new safety or effectiveness questions because FP3D's flexibility provides comfort without altering the fundamental removable denture application, and nonclinical testing demonstrates performance equivalence to the predicate.