Apex Flex

SprintRay Apex Flex is a light-curable acrylate resin used to fabricate and repair partial dentures via 3D printing in a dental office. It is intended exclusively for professional dental use and serves as an alternative to traditional thermoplastic materials, providing a removable, flexible-based partial denture that restores masticatory function and aesthetics.

Apex Flex is a light-curable acrylate-based resin manufactured via additive 3D printing, whereas the predicate devices are thermoplastic nylon materials made by injection molding. Despite these manufacturing and material differences, both achieve comparable finished device properties: Apex Flex exhibits flexural strength of 26.5 ± 0.8 MPa and flexural modulus of 748 ± 21 MPa, similar to the predicate iFlex-Star V (26.9 ± 0.7 and 612 ± 17 MPa respectively), and meets ISO 20795-1 performance standards for sorption, solubility, and monomer content.

Biocompatibility testing per FDA Blue Book Memorandum #G95-1, ISO 10993-1, and ISO 7405. Bench testing per ISO 20795-1, including flexural strength, flexural modulus, fracture work, water sorption and solubility, residual monomer, depth of cure, and accuracy fitting.

Although the subject device uses 3D printing and acrylate resin while predicates use injection molding and nylon, the finished devices share identical indications for use (flexible partial dentures), user population (dental professionals), and functional outcomes. The technological difference in manufacturing method does not alter the device's principle of operation or in vivo performance; clinical success depends on accurate design and fitting regardless of method. Performance testing demonstrates Apex Flex meets the same ISO standards and achieves comparable mechanical properties (flexural strength, modulus, sorption, solubility) and biocompatibility as the predicate devices, raising no new safety or effectiveness concerns.