Device Dossier

Orthodontic bracket, ceramic

Device Dossier for Orthodontic bracket, ceramic (Orthodontic bracket, ceramic, Class IIa, sponsor Adam Dental Supplies). ARTG record, intended purpose,…

Intended purpose

Intended purpose A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

TGA Public Summary