Multi-Unit DAS System

The Multi-Unit DAS System is a two-piece dental implant abutment consisting of a CAD-CAM fabricated zirconia superstructure bonded to a prefabricated titanium base. It is intended for use with dental implants to support single-unit or multi-unit prostheses in the maxillary or mandibular arch of partially or fully edentulous patients. The system is compatible with multiple OEM implant systems including Astra Tech, Osstem, Neodent, and Straumann.

The subject device is identical in design, materials, and manufacturing processes to the predicate device K231559. It consists of titanium alloy abutment bases (ASTM F136 / ISO 5832-3, anodized) with zirconia superstructures (ISO 13356). The multi-unit abutments have gingival heights of 1-4 mm, a 4 mm prosthetic platform diameter, and 1.4 mm post height. A new Ti-Base (coping) Engaging Interface component with 1.5 mm gingival height and 10.5 mm prepable post is included, distinguished by its engaging interface and 0° maximum angulation.

Mechanical testing per ISO 14801 for abutment performance; moist heat sterilization validated to 10⁻⁶ sterility assurance level per ANSI/AAMI/ISO 17665-1 and TIR 17665-2; biocompatibility testing per ISO 10993-5 (cytotoxicity); MRI safety evaluation per FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; zirconia material conforming to ISO 13356; cementing per Nova Resin (K213609).

The subject device is substantially equivalent to predicate K231559 because it has identical intended use, similar technological characteristics, and uses the same materials (titanium and zirconia), identical manufacturing facilities and processes, and comparable design parameters. While the new Ti-Base (coping) Engaging Interface differs in having an engaging interface and 0° angulation, risks associated with design variations are mitigated by mechanical testing per ISO 14801. The device retains the same prosthetic platform diameter, gingival height ranges, sterilization method, and packaging as the predicate.