GENIOVA aligners

GENIOVA Aligners are thermoformed plastic orthodontic aligners used to straighten permanent teeth through sequential gentle forces. Patients wear each aligner for approximately 20-22 hours daily; the aligners are removable and are replaced sequentially to gradually move teeth to their final position.

GENIOVA Aligners use Essix thermoplastic material (K062828) manufactured via thermoforming over 3D-printed models. Treatment planning employs 3Shape A/S Ortho System software (K180941). The aligners are patient-specific, non-sterile, biocompatible, and removable. Manufacturing tolerances achieve translational measurements within 0.150 mm of target values.

ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and ISO 10993-5:2009 (cytotoxicity testing). Dimensional accuracy validated using digital calipers for point-to-point and critical displacement measurements.

GENIOVA Aligners are substantially equivalent to BRIUS Clear Aligners (K202792) because they share identical regulatory classification (Class II, 21 CFR 872.5470), product code (NXC), material (Essix thermoplastic K062828), manufacturing method (thermoforming), design software (3Shape Ortho System K180941), indication for use, mode of action (continuous gentle force), and anatomical location. The material biocompatibility and physical properties were previously established for the predicate, and manufacturing validation confirms dimensional accuracy meets specifications for safe and effective use.