Device Dossier

Perio-System Combi-Pack - Dental bone matrix implant, animal-derived

Device Dossier for Perio-System Combi-Pack - Dental bone matrix implant, animal-derived (Dental bone matrix implant, animal-derived, Class III, sponsor…

Intended purpose

Geistlich Bio-Oss Collagen is intended to be used in the treatment of hard tissue defects in oral-maxillofacial surgery; and is indicated in the following clinical situations: Bone deficiencies in the alveolar ridge; Dentofacial anomalies and malformations. Geistlich Bio-Gide Perio is intended to be used in the treatment of hard and soft tissue defects in oral and maxillofacial surgery. The concerned hard and soft tissue defects may be surgically created or result from traumatic injuries, pathological conditions, medical treatments and therapies, or history of personal lifestyle habits; and is indicated to be used in the surgical treatment of the following clinical conditions: Tissue deficiencies in the alveolar ridge; Dentofacial anomalies and malformations.

Functional description

A combined kit containing Geistlich Bio-Oss Collagen 100mg and Geistlich Bio-Gide Perio 16 x 22 mm. Bio- Oss: The spongy consistency of the material allows simple trimming. The collagen facilitates adaptation to the defect site. The collagen is slowly resorbed over several weeks. Bio-Gide Perio: the duration of barrier function ensures sufficient bone formation time for the indications. The fibrous microstructure is hydrophilic and retains its structural integrity when wet.

TGA Public Summary