Device Dossier

Geistlich Bio-Oss Pen - Dental bone matrix implant, animal-derived

Device Dossier for Geistlich Bio-Oss Pen - Dental bone matrix implant, animal-derived (Dental bone matrix implant, animal-derived, Class III, sponsor…

Intended purpose

Geistlich Bio-Oss is recommended for filling of bone defects and bone augmentation, e.g. - Augmentation/reconstruction of alveolar ridges - Filling of extraction sockets - Implantology: preparation of implant sites, filling of bone dehiscences and sinus floor augmentations - Periodontology: filling of bone defects, support of the membrane during guided tissue regeneration (GTR)

Functional description

The inorganic bone matrix of has a macro- and microporous structure similar to human spongious bone. Due to the large interconnecting pore volume and the natural composition, the formation and ingrowth of new bone at the implantation site is encouraged. In the course of time Geistlich Bio-Oss is partially remodelled by osteoclasts and osteoblasts. The granules in Geistlich Bio-Oss Pen are provided in an applicator for convenience. Available in 2 granule sizes (0.25-1 mm: 1-2 mm)

TGA Public Summary