Elos Accurate Hybrid Base

The Elos Accurate® Hybrid Base™ is a two-piece dental implant abutment consisting of a titanium alloy hybrid base (bottom half) and a zirconia superstructure (top half). It attaches to dental implants using a prosthetic screw and provides support for single or multiple tooth restorations by interfacing between the implant and the zirconia crown, which is cemented to the abutment.

The subject device extends implant system compatibility to include Nuventus NV.C implant platforms (in addition to those covered by the predicate K242025). It uses identical design and manufacturing workflows (3Shape scanner, 3Shape Abutment Designer Software, CORiTEC milling unit) and design limits as the predicate, with a titanium alloy abutment component and zirconia superstructure material. The abutment features an anodized surface and the prosthetic screw is available non-coated or DLC-coated.

ISO 14801 (fatigue testing), ISO 17665-1 and ISO 17665-2 (sterilization validation), ISO 10993-1 (biocompatibility evaluation including cytotoxicity testing per ISO 10993-5). The device meets FDA guidance for Class II Special Controls per the Root-form Endosseous Dental Implants and Endosseous Dental Abutments guidance dated May 12, 2004.

The subject device is substantially equivalent to K242025 (primary predicate) because it has the same intended use, operating principle, basic design, materials (titanium alloy abutment and zirconia superstructure), and sterilization processes. The only material difference—expanded compatibility with Nuventus NV.C implant platforms—is substantiated by engineering and dimensional analysis showing compatibility, and the device does not represent a new worst-case scenario compared to documented testing in K242025. Identical design and manufacturing workflows (including identical design library constraints) and comprehensive biocompatibility testing support substantial equivalence.