9cdd8a01-1dc7-4bce-aa9b-26c10b787fefUpdatePublished42021-04-072016-02-042019-04-26Not in Commercial DistributionD768IALH60100PrimaryHIBCCTri-Nex Implant SystemIA-LH-60-10IA-LH-60-10787471015KEYSTONE DENTAL, INC.1ImplanttruefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(866)902-9272info@keystonedental.com55849Screw 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-FORMDevice Size Text, specifyOuter Diameter 3.5-9.0mmtruefalse