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Clear Aligner is indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion.

The first step is to obtain the dimensions and details of the patient's upper and lower dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (oral scans or printed models) are imported into specialized dental software for treatment planning.

The second step is to send the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we 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. A 3D printer is used to create the corresponding molds needed for this series of sequential models, and hot-press the molds into the corresponding aligners.

The final step is to thermoform the printed mold through a plastic sheet. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The thermoformed aligners are then sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3shape Ortho System™.

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