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The STR8 Clear Aligner is indicated for the aligment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

STR8 Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. STR8 Clear Aligners are designed from digital scans of a patient's dentition. Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. Once the treatment plan is reviewed and approved by a STR8 Oral Care dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are then provided to the patient by the prescribing dental professional group.