Device Dossier

Dental bonding agent, polymer based

Device Dossier for Dental bonding agent, polymer based (Dental bonding agent, polymer based, Class IIa, sponsor Healthware Aus). ARTG record, intended…

Intended purpose

An unfilled resin used to assist the mechanical adhesion of a composite restorative material to etched enamel. Bonding of direct/indirect restorations for all cavity classes using light-curing, dual-curing, or self-curing methacrylate-based composites/compomers. Bonding of fissure sealants. Enamel etching and enamel/dentine etching prior to the adhesive bonding.

TGA Public Summary