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"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (aligners) that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to Nanjing Jiahe Dental Technology Co., Ltd along with the physician's prescription. An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner travs are then manufactured by thermoforming a dental thermoplastic sheet over each model. The "Al Smile Aligners" have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.