Device Dossier

adbone BCP - Graft, bone, synthetic

Device Dossier for adbone BCP - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Australian Allografts). ARTG record, intended purpose,…

Intended purpose

adbone BCP is designed for the filling of bone voids or defects of the skeletal system that are not intrinsic to the stability of the bony structure. adbone BCP indications for use in the dental field include reconstruction of tumour voids and cyst defects, crestal augmentation, alveolar regeneration, regeneration of periodontal defects, sinus lift. adbone BCP indications for use in the orthopaedic field include repair of bone defects, arthrodesis, and osteotomies.

Functional description

adbone BCP is a synthetic, resorbable, osteoconductive, biphasic bone graft composed of 75% hydroxyapatite (HAp) and 25% beta-tricalcium phosphate (β-TCP) in the form of granules, crunch, blocks, sticks, cylinders and wedges. adbone BCP features a multidirectional interconnected porosity that guides the three-dimensional regeneration of bone. As bone healing process occurs, adbone BCP is gradually resorbed and replaced by new native bone.

TGA Public Summary