Device Dossier

Orthodontic appliance system

Device Dossier for Orthodontic appliance system (Orthodontic appliance system, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category —…

Intended purpose

The SPEED Appliance is a pre-adjusted miniaturized self-ligating appliance that employs a Super-Elastic spring clip to entrap and interact with the archwire, eliminating the need for ligature ties. The spring clip snaps open to allow for archwire insertion and snaps closed to entrap the archwire. The SPEED Appliance and complementary auxiliary products are a fixed appliance orthodontic system intended to treat malocclusions (a malocclusion is a misalignment of teeth and/or incorrect relation between the teeth of the two dental arches) and are intended for professional use only.

TGA Public Summary