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The Straight T Clear Dental Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

A dental health professional (e.g. orthodontist or dentist) prescribes the Straight T Dental Aligners based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. Straight T Clear Dental Aligner are intraoral thermoformed plastic aligners that are worn 20 to 21 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Straight T Clear Dental Aligners are fabricated using a three-step process. The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Straight T Dental utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment is complete.