S.I.N. Dental Implant System

The S.I.N. Dental Implant System is a dental implant device intended for placement in the upper or lower jaw to support single or multiple tooth restorations. It can be immediately loaded after placement when good primary stability is achieved and appropriate functional load is applied. Custom abutments designed using CAD-CAM software must be manufactured by S.I.N.-validated milling centers.

The subject device adds Interface Abutments with MT 16° and CM11.5° connections and Healing Abutments to the existing S.I.N. system. Interface Abutments are two-piece titanium-zirconia abutments with platform diameters of 3.5–5.5 mm, post heights of 4.0–6.0 mm, and gingival heights of 0.5–4.0 mm, designed only in straight configurations. All components are manufactured from titanium alloy (ASTM F136) or zirconia (ISO 13356) and sterilized by gamma irradiation.

ISO 10993-5 (cytotoxicity), ANSI/AAMI/ISO 17665-1 and TIR 17665-2 (moist heat sterilization), ISO 14801 (mechanical testing), ASTM F2052 (magnetic displacement), ASTM F2213 (magnetic torque), ASTM F2182 (RF heating), ASTM F2119 (image artifact), and ASTM F136 and F1537 (material specifications).

The subject device is substantially equivalent to predicate devices K193096, K170392, and K200992 because it has identical indications for use, same materials (titanium and zirconia), identical sterilization methods (gamma irradiation), compatible abutment-implant connections, and the same design principles. The minor dimensional differences do not impact safety or effectiveness, and previous mechanical testing per ISO 14801 is applicable to the subject device.