Device Dossier
Orthodontic bracket, ceramic
Device Dossier for Orthodontic bracket, ceramic (Orthodontic bracket, ceramic, Class IIa, sponsor Henry Schein Halas). ARTG record, intended purpose,…
- GMDN category: Orthodontic bracket, ceramic
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.