Conical Ti Base abutments

The Conical Ti Base abutments are two-piece dental prosthetic components consisting of a pre-manufactured titanium base and a customized zirconia superstructure. They connect to endosseous dental implants to support single or multi-unit prosthetic restorations in the maxillary or mandibular arch. The zirconia superstructure can be fabricated either at a BioHorizons validated milling center or via a digital dentistry workflow integrating intra-oral scanning, CAD/CAM design, and milling.

The titanium bases are manufactured from Ti-6Al-4V alloy per ASTM F136, available in narrow and regular platforms with gingival heights of 0.8 mm and 2.0 mm, in both engaging and non-engaging designs. The zirconia superstructure uses sagemax NexxZr material bonded with 3M RelyX Unicem 2 cement. Digital design employs 3Shape Trios 5 scanner, 3Shape Abutment Designer Software (K151455), hyperDENT CAM software, and imes-icore CORiTEC 150i Pro milling machine with design limitations including 20° maximum angulation, 0.4 mm minimum wall thickness, and 5 mm maximum gingival margin height.

ASTM F136 (titanium alloy specification for surgical implants) and ISO 10993-1 (biocompatibility evaluation). Surface characterization was performed using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDX).

The subject device is substantially equivalent because it uses identical titanium materials (Ti-6Al-4V per ASTM F136), identical zirconia superstructure materials and cement, the same manufacturing platform (imes-icore CORiTEC 150i Pro), and identical design software (3Shape K151455) as the primary predicate K240187. The final abutment design, dimensions, angulation limits, wall thickness, and intended single-use non-sterile format are identical to the predicate. The primary difference—adding digital dentistry workflow capability alongside the validated milling center pathway—does not change the technological characteristics or safety profile, as both methods produce identical final abutments. The secondary predicate K231307 provides precedent for digital workflow indications. No new materials are introduced and all biocompatibility, mechanical, and sterilization testing data rely on the predicate submissions.