Device Dossier
Orthodontic inter-bracket elastic chain
Device Dossier for Orthodontic inter-bracket elastic chain (Orthodontic inter-bracket elastic chain, Class IIa, sponsor Honour International Trading).…
- GMDN category: Orthodontic inter-bracket elastic chain
Intended purpose
A non‐sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single‐patient device intended to be replaced regularly during orthodontic treatment (single‐use).