Device Dossier

SureSmile Aligners and Trays - Orthodontic appliance system, progressive

Device Dossier for SureSmile Aligners and Trays - Orthodontic appliance system, progressive (Orthodontic progressive aligner, Class IIa, sponsor Dentsply…

Intended purpose

Aligners are intended to align teeth into position and treatment of tooth malocclusion in patients with permanent dentition. Attachment Transfer Trays are a separate plastic transfer tray that incorporates pockets corresponding to the location(s) and geometry of the preplanned attachments (a.k.a. bumps to guide the applied force and moment) that are provided to clinicians, aiding them with the placement of attachments/bumps when requested/needed as part of the treatment plan. System contains Aligners and Attachment Trays

TGA Public Summary