ZENEX Implant System_Short (R-System)

The ZENEX Implant System_Short (R-System) is a titanium dental implant fixture measuring 6.25mm in length with diameters ranging from 5.05 to 6.75mm, designed to be placed in the jawbone to support tooth restorations. It is indicated for partially or fully edentulous patients requiring single or multiple unit restorations, cemented or screw-retained, with delayed loading in the molar region; short and wide implants must be splinted in areas of poor bone quality or high occlusal forces.

The subject device uses pure titanium (ASTM F67 Grade 4) with a tapered body, internal hex connection, sandblasted and acid-etched surface treatment, and self-tapping cutting edges. The only difference from the primary predicate is the connection design: this device employs a 5° tapered internal hex connection matching the reference predicate K252585, rather than a standard internal hex connection.

ISO 14801:2016 (fatigue testing), ISO 10993 series (biocompatibility), ISO 11137-1/2/3 (sterilization validation), ASTM F1980 (shelf life testing), and FDA guidance documents on root-form endosseous dental implants and MR environment safety.