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The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Orthocaps TwinAligner® System consists of a series of custom made removable clear plastic orthodontic aligners that sequentially positions teeth by way of continuous gentle force. An electronic scan or mold impression of the patient's teeth in an untreated state is provided by a dental or orthodontic professional. From the digital scan, Orthocaps technicians design a series of intermediate models corresponding to each stage of treatment intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Orthocaps produces the aligner trays formed from clear, thin thermoformed plastic. The trays are sent back to the physician for patient fit and treatment. Additional trays are provided sequentially to gradually move the target teeth to the designed position, which is monitored throughout treatment by the physician. The aligner trays are held in place by pressure and can be removed by the patient at any time. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printed files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation for this subject device is the 3Shape reference predicate.