Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue

The Neodent Gold Hue Custom Abutments and Medentika Custom Abutments Gold Hue are customized prosthetic abutments manufactured from titanium alloy with a titanium nitride coating on the emergence profile and coronal aspect, giving them a gold color. They are placed on dental implants to support customized prosthetic restorations (crowns, bridges) and are digitally designed and milled at Straumann's validated centers. The devices are intended for single or multiple tooth restorations in partially or fully edentulous patients.

Both subject devices are one-piece titanium alloy (Ti6Al4V ELI per ASTM F136) abutments with titanium nitride coating, custom-designed via CAD/CAM and milled at validated centers. They feature implant-specific connection geometries, support both screw- and cement-retained restorations, have minimum wall thickness of 0.4 mm to screw channels, and are compatible with multiple implant systems and diameters. The key distinguishing feature is the titanium nitride coating on the emergence profile, which is supported by predicate K162848 (Straumann CARES Golden Ti/TiN Abutments).

ASTM F136 (wrought titanium-6 aluminum-4 vanadium for surgical implants); ASTM F1044 (shear testing of metallic coatings); ASTM F1160 (shear and bending fatigue of metallic coatings); ISO 17665-1 and ISO/TS 17665-2 (moist heat sterilization validation); ISO 14801:2016 (dynamic loading test for endosseous dental implants); Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Abutments.

The subject devices are substantially equivalent to predicates K250614 (Neodent Custom Abutments AS) and K223113 (Medentika CAD/CAM Abutments) based on identical intended use, indications, materials, design workflow, manufacturing process, and sterilization methods. The titanium nitride coating is supported by predicate K162848 (Straumann CARES Golden Ti/TiN Abutments), which demonstrates the same coating process and materials. No new implant connections or design solutions are introduced, and performance testing confirms equivalent function.