Device Dossier
EthOss TCP - Dental bone matrix implant, synthetic
Device Dossier for EthOss TCP - Dental bone matrix implant, synthetic (Dental bone matrix implant, synthetic, Class III, sponsor W9 Pty Ltd). ARTG…
- GMDN category: Dental bone matrix implant, synthetic
Intended purpose
EthOss TCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Functional description
EthOss TCP is a synthetic, resorbable, osteoconductive bone graft material composed of 65% beta tricalcium phosphate (β-TCP) and 35% medical grade calcium sulfate (CaSO4). It is provided as a dry powder packaged within a syringe to be mixed with sterile saline to form a paste and applied through the syringe.