LuxAlign: First FDA Class II 510(k) Cleared Direct Print Aligner
Inside Dental Technology delivers updates on digital workflows, materials, lab techniques, and innovation in dental technology through expert articles and videos.
May 1, 2023
Volume 14, Issue 5, May 2023
Page(s): p. 4
LuxCreo announced the FDA Class II 510(k) clearance of LuxAlign® , its end-to-end solution for direct printing of clear aligners, bypassing traditional model and thermoforming stages. "LuxCreo direct print aligners offer higher accuracy compared to thermoformed alternatives, which can result in a better patient fit," says LuxCreo CEO Mike Yang.
The workflow utilizes Direct Clear Aligner
Material (DCA), which is tough, flexible, and accurate with high transparency and no manual polishing needed, enabled by LuxCreo's Digital Polishing™ technology.
The iLux Pro Dental is a high-throughput, small-footprint, heated DLP printer with 50-µm pixel resolution powered by LEAP™ technology. LuxAlign® design software allows users to automatically generate designs, add trimlines, repair tooth gaps, and vary aligner thickness. The iLuxCure Pro is a programmable, multi-wavelength, multi-direction post-print cure.
LuxCreo
luxcreo.com | 650-336-0888
iLux Pro Dental and DCA
} Print up to 175 models horizontally or up to 64 direct aligners in an 8-hour shift on the iLux Pro Dental
} Direct Clear Aligner Material (DCA) is tough, flexible, and accurate with high transparency and no manual polishing needed
} DCA has been FDA Class II 510 (k) cleared for an aligner indication
