Device Dossier

Orthodontic bracket, metal

Device Dossier for Orthodontic bracket, metal (Orthodontic bracket, metal, Class IIa, sponsor ORTHOSTATE). ARTG record, intended purpose, GMDN category —…

Intended purpose

Orthodontic brackets are intended for use in orthodontic mechanics to correct sagittal, vertical and transverse, inter-arch and intra-arch malocclusions. The brackets are fixed to the buccal surface of the teeth to accommodate intraoral orthodontic archwires and interact with other orthodontic accessories, enabling the application of forces to the teeth to produce controlled tooth movement and correction of malocclusion.