Device Dossier

ZenGro Xenograft Bone Mineral - Dental bone matrix implant, animal-derived

Device Dossier for ZenGro Xenograft Bone Mineral - Dental bone matrix implant, animal-derived (Dental bone matrix implant, animal-derived, Class III,…

Intended purpose

ZenGro is a sterile, biocompatible anorganic porous bone mineral for use in periodontal, oral and maxillofacial surgery. It is indicated as follows: - 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 intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Functional description

The anorganic bone matrix of ZenGro™ has interconnecting macro- and microscopic porous structure that supports the formation and ingrowth of new bone at the implantation site. ZenGro™ may be considered when autogenous bone is not indicated, or insufficient in quantity to fulfill the needs of the proposed surgical procedure.

TGA Public Summary