Fas Aligner System

The Fas Aligner System is a series of customized removable plastic orthodontic appliances that sequentially reposition teeth using continuous gentle force to treat malocclusion. Patients wear each aligner for approximately 1-2 weeks at 20-22 hours per day before advancing to the next stage, similar to conventional aligner-based orthodontic treatment.

The device uses sequential thermoformed plastic aligners made from PET-G thermoplastic polymer (Erkodur, K200125) manufactured via thermoforming on 3D-printed models. The primary technological difference from the predicate is that Fas Aligner System uses FDA-cleared Nemocast software (K232549) for treatment planning, whereas the predicate Nuvola® Aligner uses 3Shape Ortho System software, though both generate digital treatment plans and intermediate steps to produce customized aligners.

Biocompatibility testing was conducted per ISO 10993-1 (Biological evaluation of medical devices). Only cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured aligner. Manufacturing process validation was conducted internally to demonstrate robustness from 3D printing through thermoforming.

The Fas Aligner System has identical intended use (orthodontic treatment of malocclusion), same regulatory classification (Class II, 21 CFR 872.5470, product code NXC), same materials (PET-G), same manufacturing process (thermoforming on models), same design description (sequential aligners), and same principles of operation as the predicate Nuvola® Aligner. Although the software differs, the applicant argues this difference does not raise new questions of safety or efficacy because both Nemocast and 3Shape Ortho System perform equivalent functions—converting digital scans into intermediate treatment steps and customized aligners—and Nemocast is itself FDA-cleared.