Device Dossier

Resin-composite dental cement

Device Dossier for Resin-composite dental cement (Resin-composite dental cement, Class IIa, sponsor One Dental). ARTG record, intended purpose, GMDN…

Intended purpose

A non-sterile, polymer-based substance dispensed as a paste, powder, and/or liquid typically consisting of polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA) with filler(s), pigments, polymerization initiator, and accelerators intended to be used in the cementation of dental restorations or appliances (e.g., inlays, onlays, veneers, crowns, or bridges) to the oral anatomy or other devices. It may be a light-cured, dual-cured, and/or self-cured product. After application, this device cannot be reused.

TGA Public Summary