ZENEX Implant System_R-System

The ZENEX Implant System_R-System is a titanium dental implant system designed for partially or fully edentulous patients. It supports single or multiple tooth restorations including cemented, screw-retained, or overdenture restorations, with delayed loading intended. The wide fixture system is for molar region placement.

The device consists of two fixture types (MULTI and PLUS) with diameters ranging 3.85–6.75 mm and lengths 7–15 mm, made of pure titanium Grade 4 with SLA surface treatment. It includes compatible abutments (cover screws, healing abutments, cemented and angled abutments, temporary abutments, ball abutments, multi abutments, cast abutments, and free-milling abutments) made of Ti-6Al-4V ELI with optional TiN coating. The primary difference from predicate K211090 is the internal connection dimensions and shape, adopting the reference device K140091 connection interface.

ISO 14801:2016 (fatigue testing), ISO 10993 series (biocompatibility), ISO 11137-1/2/3 (gamma sterilization), ASTM F1980 (shelf life), ANSI/AAMI ST72:2011 and ST79 (bacterial endotoxin and sterilization validation), ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1, and FDA guidance for root-form endosseous dental implants.

The subject device is substantially equivalent to primary predicate K211090 because it shares identical intended use, material composition, manufacturing process, surface treatment, and sterilization method. Although the internal connection interface differs to adopt the design from reference device K140091, the diameter and length combinations are fully covered by the predicate range. Fatigue testing validated mechanical safety under worst-case scenarios, and biocompatibility and sterilization testing were leveraged from predicates, demonstrating these differences do not affect fundamental function or safety.