HEXIM Implant; Samwon General Abutments

The HEXIM Implant is a threaded root-form endosseous dental implant with an internal hexagon connection, designed to be surgically inserted into the jawbone to support single or multiple-unit restorations. The Samwon General Abutments are companion components (cover screws, healing abutments, couple abutments, and abutment screws) that connect to the implant to support prosthetic restorations such as crowns, bridges, or overdentures after osseointegration.

The HEXIM Implant is made of CP Ti Grade 4 with SLA surface treatment, has an internal hex connection, and comes in diameters of 4.2–6.0 mm and lengths of 7.0–13 mm. It includes a bottom cavity with 5 perpendicular channels for bone fixation. The Samwon abutments are made of Ti-6Al-4V ELI, have no surface treatment, and include healing abutments with gingival heights of 3.5–7.5 mm and couple abutments with gingival heights of 0.9–3.9 mm. All components use threaded connections and are sterilized by gamma irradiation (implant) or end-user steam sterilization (abutments).

ISO 11137 (gamma sterilization validation), ISO 17665 (steam sterilization), ASTM F1980 (accelerated aging), ISO 10993 series (biocompatibility), ISO 14801:2007 (fatigue testing), USP 41 and ANSI/AAMI standards (endotoxin testing and sterilization assurance). The submission references the FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

The HEXIM Implant matches the predicate device (Tapered Screw-Vent M, K111889) in base material, internal hex connection type, and principle of operation as a threaded root-form fixture for delayed-loading support of dental restorations. Although the subject device's diameters and lengths differ slightly, they fall within the predicate's range and do not affect safety or efficacy. The Samwon abutments share the same intended use, material composition (Ti-6Al-4V ELI), sterilization method, and mechanical function as the predicate abutment components (S-Plant, K221866). Minor dimensional differences in abutment diameters, gingival heights, and screw lengths are within legally marketed device ranges or supported by mechanical testing per FDA guidance, confirming substantial equivalence.