Device Dossier

Neomem FLEXPLUS - Collagen dental regeneration membrane

Device Dossier for Neomem FLEXPLUS - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor My Biologics). ARTG…

Intended purpose

This resorbable porcine collagen dental membrane is a bioresorbable, implantable collagen material that is intended for use in oral surgical procedures as a resorbable membrane material for use in, simultaneous use of guided bone regeneration (GBR)-membrane and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy or removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration in periodontal defects.

Functional description

This resorbable porcine collagen dental membrane acts as a barrier membrane for Guided Tissue Regeneration (GTR) or Guided Bone Regeneration (GBR). It effectively retards epithelial down growth and prevents gingiva connective cell migration into the wound site.

TGA Public Summary