Device Dossier
Orthodontic archwire
Device Dossier for Orthodontic archwire (Orthodontic archwire, Class IIa, sponsor Dentsply Sirona). ARTG record, intended purpose, GMDN category —…
- GMDN category: Orthodontic archwire
- Sponsor: Dentsply Sirona
Intended purpose
Orthodontic Wires are intended to be used in addition to brackets or attachments to form a complete appliance to move natural teeth. The wire is tied to the bracket system and deflected when tied to misaligned teeth. The force from the deflection moves the tooth in the desired direction to align the teeth during orthodontic treatment. Wires are prescribed devices that can only be attached to the bracket system by a clinician. The wire is customized as it is heat treated and bent based on the specific doctor’s orders for that patient.