Elos Accurate® Hybrid Base™

The Elos Accurate® Hybrid Base™ is a two-piece dental implant abutment consisting of a titanium alloy hybrid base component and a zirconia superstructure. It attaches to endosseous dental implants using a prosthetic screw and provides a foundation for single or multiple tooth prosthetic restorations, with the zirconia crown cemented to the hybrid base.

The device is available in engaging and non-engaging variants with four collar heights and a 7.5 mm chimney cuttable to minimum 3.5 mm. It uses titanium alloy (ASTM F136) for the abutment and screw, with a gold anodized surface finish on the abutment (identical to predicate K230317) and anodized screws (identical to reference K120414). The main difference from the predicate is expanded implant system compatibility to include Astra Tech EV platforms (3.0, 3.6, 4.2, 4.8, 5.4 mm) in addition to prior compatibility, substantiated by engineering analysis and new fatigue testing.

ISO 14801 (fatigue testing per FDA Class II guidance for endosseous dental implants and abutments, May 2004); ISO 17665-1 and ISO 17665-2 (sterilization validation); ISO 10993-1 and ISO 10993-5 (biocompatibility and cytotoxicity testing); ASTM F136 (titanium alloy specification).

The subject device is substantially equivalent because it has identical intended use, design principle (two-piece screw-retained/cement-retained abutment), materials, and sterilization processes as predicate K230317. Although implant platform compatibility is expanded to Astra Tech EV systems, dimensional analysis and fatigue testing demonstrate mechanical performance comparable to the predicate. The zirconia superstructure design and manufacturing workflow (3Shape software, CORiTEC milling, Lava Plus zirconia) is identical to the predicate, with identical design limits built into the digital library, meaning new variants do not represent a worse-case scenario than already validated in K230317.