Device Dossier
Ti-oss - Dental bone matrix implant, animal-derived
Device Dossier for Ti-oss - Dental bone matrix implant, animal-derived (Dental bone matrix implant, animal-derived, Class III, sponsor Biogen Medi). ARTG…
- GMDN category: Dental bone matrix implant, animal-derived
Intended purpose
Ti-oss is intended for use in bone regeneration and augmentation of oral and maxillofacial bone defects with or without products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Alveolar ridge defects. - Sinus Augmentation. - Extraction defects (or alveolar ridge preservation or socket preservation). - Periodontal defects. - Peri-implant defects. - Apicoectomies. - Cystectomies.
Functional description
Ti-oss is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Ti-oss® is packaged and sterilized using gamma irradiation. Ti-oss has a highly cancellous structure similar to human bone demonstrated under high magnification.