SureSmile Aligner (ASSY500020)

SureSmile Aligners are removable orthodontic devices made from clear thermoformed plastic that apply continuous gentle force to progressively reposition teeth to correct malocclusion. Patients wear sequential aligners for 1-2 weeks at 20-22 hours per day, replacing each with the next stage aligner, with treatment duration determined by the treating clinician's prescription.

The device uses thermoplastic polymer PET-G material thermoformed on 3D models to create sequential clear aligners customized for each patient. It is manufactured using the same materials and processes as the predicate device and employs SureSmile Software for digital treatment planning. The device may include attachments, slits, and cutouts to enhance force delivery.

ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Irritation), ISO 10993-11 (Material Mediated Pyrogenicity and Acute Systemic Toxicity), ISO 10993-3 (Genotoxicity), and ISO 10993-18 (Chemical Analysis) for biocompatibility evaluation.

The SureSmile Aligner is substantially equivalent to the predicate Nuvola Aligner because both devices have identical indications for use (orthodontic treatment of malocclusion), same in-use duration and patient populations (children, adolescents, and adults), and the same or very similar technological characteristics including materials, manufacturing process, and operating principle. This submission clarifies labeling only, removing the restriction 'in patients with permanent dentition.'