Hard Splint & Thermo-Adaptive Splint

Hard Splint and Thermo-Adaptive Splint are 3D-printable light-curable resins used to fabricate orthodontic and dental appliances including splints, mouthguards, nightguards, repositioners, and retainers. Hard Splint produces rigid appliances while Thermo-Adaptive Splint produces flexible ones. Both are used with a complete additive manufacturing system including scanner, design software, 3D printer, and curing unit.

Both devices are photocurable resins used in additive manufacturing with the same critical specifications and manufacturing methods as the predicate KeyPrint KeySplint Soft. Although the chemical composition differs from the predicate, all materials fall into the same photocurable resin category. The resins are also technologically similar to reference device VeriSplint (K190107), using comparable design software, scanner, printer software, and 3D printer technology.

ISO 20795-2 (flexure properties, fracture properties, water sorption and solubility, residual methyl methacrylate). Whip Mix internal requirements were also applied for flexure properties and water sorption/solubility testing.

The devices demonstrate substantial equivalence because they share the same product codes (MQC, KMY), identical indications for use, and comparable material categories (photocurable resins) as the predicates. Testing shows equivalent or superior mechanical performance and biocompatibility to the predicate. The manufacturing methods and critical specifications are substantially equivalent despite differences in chemical composition, as all materials serve the same functional purpose in additive manufacturing of dental appliances.