Device Dossier

OSSIX Plus - Collagen dental regeneration membrane

Device Dossier for OSSIX Plus - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor Dentsply Sirona). ARTG…

Intended purpose

A resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier.

Functional description

A collagen, porous membrane that prevents the ingrowth of fibrous tissue into the defect while allowing free transfer of the body fluids and ingrowth of bone-forming cells. The fibrous microstructure is hydrophilic and readily absorbs fluids and retains its structural integrity when wet. In vivo degradation of the membrane takes several months. The membrane is not radio-opaque.

TGA Public Summary