0a9141bd-bc2f-449d-869c-62c28e71a882NewPublished12019-09-032019-08-26In Commercial Distribution08809488216628PrimaryGS1J2C SLA Dental Implant SystemMTF6015RP688476027KJMEDITECH.CO.,LTD1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK16192300055849Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), 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.trueActiveDZEImplant, Endosseous, Root-Formtruefalse