Neodent Implant System - Custom Abutments

The Neodent Implant System - Custom Abutments are customized prosthetic abutments manufactured in titanium alloy, designed to attach to dental implants and support prosthetic restorations (copings and crowns). They are digitally designed and manufactured via CAD/CAM software at a Straumann validated milling center and are indicated for screw-retained single restorations or cement-retained single or multiple restorations.

The proposed device features an angled screw channel (maximum 25° angulation) with titanium alloy material per ASTM F136, compatible with Grand Morse (GM), Narrow Grand Morse (NGM), and Helix Short (HS) implant connections. Key dimensions include 0.4 mm minimum wall thickness, 4 mm minimum abutment post height, and gingival heights up to 8.6 mm for GM/NGM interfaces. It differs from the predicate by offering an angled-only channel design versus the predicate's straight and angled options.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1 (biological evaluation), ISO 10993-5 (cytotoxicity), ISO 10993-18 (chemical characterization), ISO 17665-1 (sterilization validation for moist heat), and FDA guidance for Class II dental implants and abutments.

The devices are substantially equivalent because they share identical indications for use, material composition (titanium alloy per ASTM F136), manufacturing workflow (Straumann centralized milling), sterilization method (moist heat to SAL 1×10⁻⁶), biocompatibility profile, and overall design parameters with the predicate K233857. The only difference—introduction of an angled-only screw channel—represents a narrowing rather than expansion of the predicate's capabilities (which offered both straight and angled options), making it a subset of already-cleared technology with no new worst-case performance parameters.