Device Dossier

Dental implant system

Device Dossier for Dental implant system (Dental implant system, Class IIb, sponsor Henry Schein Halas). ARTG record, intended purpose, GMDN category —…

Intended purpose

These sterile endosteal dental implants of iSy Implant System are intended for oral endosseous implantation in the maxillary and or mandibular bone. The implants can be loaded immediately if the primary stability achieved for functional loading is adequate. The prosthetic restoration occurs with crowns, bridges and overdentures, hence this implant system basically helps provide support as well as means of retention for a dental prosthesis.

TGA Public Summary