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Indicated for use in alignment of teeth through orthodontic treatment of malocclusion.

This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features. The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage. The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition. Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage.

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect. The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.