Device Dossier

Light-cured dental restorative composite resin

Device Dossier for Light-cured dental restorative composite resin (Light-cured dental restorative composite resin, Class IIa, sponsor Vicdent). ARTG…

Intended purpose

This is a dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, photo-polymerizable, organic resin matrix that is typically used to fill dental cavitie. It is typically a single-paste system consisting of a dimethacrylate resin, and either a mixture of bisphenol A and glycidylmethacrylate (BISGMA) or urethane dimethacrylate (UDEMA); the filler is usually made of glass, quartz, ceramic, or silica combined with 5-10% weight of very small-sized particles of colloidal silica. This single-use product should match the colour of the original teeth for aesthetic reasons.

TGA Public Summary