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…
- GMDN category: Orthodontic progressive aligner
- Sponsor: Dentsply Sirona
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