Device Dossier

Resin-composite dental cement

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

Intended purpose

The basic material are Nano Hybrid Composite and Veneer Bond. Both CE labelled medical device which are used for adhering composite veneers, filling treatment of cavities and the modelling of tooth defects as well as filling and modelling of missing tooth sections. In dentistry terms they are referred as caries, old restorations, extensions of incisal edges, malposition of teeth, tooth fractures, discoloration of teeth, discoloration, anatomical malformation, diastema, attrition, abrasion, erosion, cosmetic corrections. The raw material of the nano hybrid composite are barium glass in a Bis-GMA based matrix of dental resins with pigments, additives and catalysts. The material may only be supplied to dentists and dental laboratories or on their behalf.

TGA Public Summary