Device Dossier

Socket Repair Membrane - Collagen dental regeneration membrane

Device Dossier for Socket Repair Membrane - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor ZimVie).…

Intended purpose

A sterile, bioabsorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and/or to regenerate bone or bone defects around dental implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material which may be fixed with sutures; it is applied between soft tissue and bone, and/or to bone defects [e.g., during periodontal flap surgery, guided bone regeneration (GBR), and/or guided tissue regeneration (GTR) procedures]. This is a single-use device.

Functional description

Intended for use in oral surgical procedures as a resorbable membrane material used in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

TGA Public Summary