Device Dossier
Orthodontic appliance, ligature
Device Dossier for Orthodontic appliance, ligature (Orthodontic appliance, ligature, Class IIa, sponsor Dentaurum). ARTG record, intended purpose, GMDN…
- GMDN category: Orthodontic appliance, ligature
Intended purpose
This is a device intended to be used to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).