Device Dossier

Dental appliance fabrication material, resin

Device Dossier for Dental appliance fabrication material, resin (Dental appliance fabrication material, resin, Class IIa, sponsor Emergo). ARTG record,…

Intended purpose

TERA HARZ CLEAR is a clear designed for the treatment of malocclusions in patients with permanent dentition (i.e. all second molars). It employs a series of incremental tooth movements to position teeth sequentially by applying continuous gentle force. It is intended for use by qualified professionals only. The fabrication of an orthodontic aligner with TERA HARZ CLEAR necessitates the utilisation of an Additive Manufacturing System (AMS), which encompasses the following compatible components: scanner, design software, additive printer and post-curing unit.

TGA Public Summary