Device Dossier

Spark™ Clear Aligner System - Orthodontic appliance system, progressive

Device Dossier for Spark™ Clear Aligner System - Orthodontic appliance system, progressive (Orthodontic progressive aligner, Class IIa, sponsor Ormco).…

Intended purpose

The Spark™ Clear Aligner System is a series of clear orthodontic appliances indicated for the alignment of teeth during orthodontic treatment of malocclusion. The Spark™ Clear Aligner System is intended to position teeth by way of continuous gentle force during orthodontic treatment of malocclusion. The optional integrated occlusion guide features allow the option of forward repositioning of the mandible to a more optimal bite profile.

TGA Public Summary