Device Dossier

Maxresorb - Graft, bone, synthetic

Device Dossier for Maxresorb - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Botiss). ARTG record, intended purpose, GMDN category —…

Intended purpose

Maxresorb® is a synthetic osteoconductive bone substitute in granulate form intended to be used as a scaffold to support the in-growth of adjacent viable bone in defects that are not intrinsic to the stability of the bone structure. It is intended for the filling of intraosseous, periodontal and root resection defects, for filling of extraction alveolae, for elevation of the maxilliary sinus floor and for augmentation or reconstructive treatment of the alveolar ridge.

Functional description

Maxresorb® is supplied sterile in granular form. It is a mixture having a nominal composition of 60% Hydroxyapatite and 40% Tricalcium Phosphate. It is s fully biocompatible material which acts as an osteoconductive scaffold to support the in-growth and fusion of adjacent bone when placed in an osseous environment.

TGA Public Summary