Device Dossier

OSSIX Bone - Dental bone matrix implant, synthetic

Device Dossier for OSSIX Bone - Dental bone matrix implant, synthetic (Dental bone matrix implant, synthetic, Class III, sponsor Dentsply Sirona). ARTG…

Intended purpose

An osteoconductive bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

Functional description

A spongy, porous scaffold composed of collagenized hydroxyapatite at a mass ratio of 20% collagen and 80% the inorganic mineral particles. The collagen prevents migration of the hydroxyapatite particles and facilitates adaptation to the defect site. The macro and microporous structure of the scaffold allow the infiltration of the bone forming cells, ingrowth of new bone at the implantation and eventually bone remodeling by osteoclasts and osteoblasts.

TGA Public Summary