Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

The Omnibut is a pre-manufactured dental implant abutment that connects directly to endosseous (bone-anchored) dental implants to support screw-retained prosthetic tooth replacements. It is used for multiple-unit reconstructions in the upper or lower jaw to restore chewing function and is compatible with multiple implant system platforms including Neodent, NobelActive, Straumann BLX, and Zimmer Tapered Screw-Vent implants.

The Omnibut features a ball abutment with a retention attachment allowing angular correction up to 30° off the implant axis, compared to the predicate which also supports 0–30° angulation. Both are made from Ti-6Al-4V alloy, use internal abutment-implant interfaces, employ integral screws for fixation, are single-use non-sterile devices, and support 4.8 mm platform diameter multi-unit screw-retained restorations. Key difference is the Omnibut's differently designed components and variable angulation mechanism, though performance characteristics remain equivalent.

ISO 14801:2016 (dynamic fatigue loading), ISO 10993-1:2018 and ISO 10993-5:2009 (biocompatibility and cytotoxicity), ASTM F136 (titanium alloy specification), ANSI/AAMI/ISO 17665-1 and TIR 17665-2 (steam sterilization validation), ANSI/AAMI ST79:2017 (sterilization standards), and FDA guidance on Class II dental implant abutments (May 2004).

The device is substantially equivalent because it shares identical intended use (supporting multi-unit screw-retained prostheses on endosseous implants), identical materials (Ti-6Al-4V ELI), identical abutment-implant interface type (internal), and equivalent performance across comparable implant platforms as demonstrated by dynamic fatigue testing, biocompatibility evaluation, and retention force testing using the same standards as the predicate. The technological differences in design and angulation mechanism do not raise different safety or effectiveness questions because mechanical testing confirms equivalent functional performance under clinical loading conditions.