Device Dossier

Geistlich Bio-Gide - Collagen dental regeneration membrane

Device Dossier for Geistlich Bio-Gide - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor Geistlich…

Intended purpose

Geistlich Bio-Gide is intended to be used in the treatment of hard and soft tissue defects in oral and maxillofacial surgery. The concerned hard and soft tissue defects may be surgically created or result from traumatic injuries, pathological conditions, medical treatments and therapies, or history of personal lifestyle habits. Geistlich Bio-Gide is indicated to be used in the surgical treatment of the following clinical conditions: Tissue deficiencies in the alveolar ridge; Dentofacial anomalies and malformations.

Functional description

The devices porous surface facing the bone allows for the ingrowth of bone-forming cells. The dense surface facing the soft tissue prevents the ingrowth of fibrous tissue into the defect. The fibrous microstructure is hydrophilic and readily absorbs fluid and retains its structural integrity when wet. In vivo degradation of the membrane takes several months depending on the surgical site, vascularization and patient comorbidities. The membrane is not radio-opaque.

TGA Public Summary