Device Dossier
Screw endosteal dental implant, two-piece
Device Dossier for Screw endosteal dental implant, two-piece (Screw endosteal dental implant, two-piece, Class IIb, sponsor Nobel Biocare). ARTG record,…
- GMDN category: Screw endosteal dental implant, two-piece
Intended purpose
A sterile device made of alloplastic materials (e.g., titanium, stainless steel, ceramic) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.