Device Dossier
Reguarde™ Resorbable Collagen Membrane - Collagen dental regeneration membrane
Device Dossier for Reguarde™ Resorbable Collagen Membrane - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III,…
- GMDN category: Collagen dental regeneration membrane
Intended purpose
A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around 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 made of animal derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery applied to grafted bone defects in guided bone regeneration (GBR) and guid tissue regeneration (GTR) procedures. This is a single-use device.
Functional description
Cytoplast™ Collagen Membranes is a resorbable, cell-occlusive barrier membranes used in guided tissue and bone regeneration procedures in oral surgery to manage oral wounds and assist in wound healing.