Device Dossier

ZenGuard - Collagen dental regeneration membrane

Device Dossier for ZenGuard - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor Southern Implants). ARTG…

Intended purpose

ZenGuard™ 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; and - guided tissue regeneration procedures in periodontal defects.

Functional description

ZenGuard™ 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