Device Dossier

creos xenogain collagen - Dental bone matrix implant, animal-derived

Device Dossier for creos xenogain collagen - Dental bone matrix implant, animal-derived (Dental bone matrix implant, animal-derived, Class III, sponsor…

Intended purpose

creos xenogain collagen is recommended for: -Augmentation or reconstructive treatment of the alveolar ridge. -Filling of infrabony periodontal defects. -Filling of defects after root resection, apicoectomy, and cystectomy. -Filling of extraction sockets to enhance preservation of the alveolar ridge. -Elevation of the maxillary sinus floor. -Filling of periodontal defects in conjunction with products intend for Guided Tissue Regeneration (GTR)and Guided Bone Regeneration (GBR). -Filling of peri-implant defects in conjunction with product intended for Guided Bone Regeneration (GBR).

Functional description

creos xenogain collagen is a combination of purified cancellous bovine bone mineral granules (creos xenogain) and 10 percent porcine collagen in block form in a blister pack, or in a cylindrical form in a syringe and a blister pack. It is sterilized by gamma irradiation.

TGA Public Summary