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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for singleunit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N. - validated milling center for manufacture.

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. The K170392 submission included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. Components cleared in K 170392 included the Unitite line of dental implants that have a threaded endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA""). All other dental implants cleared in K170392 had a threaded endosseous surface that was acid-etched only (no HA100). This submission adds the following components to the S.I.N. Dental Implant System: the identical HA1000 coating to the Strong SW CM (Morse taper) implant line cleared in K170392; the identical HA™® coating to the Strong SW HE (external hexagon) implant line cleared in K170398; the identical HA-"00 coating to the Strong SW HI (internal hexagon) implant line cleared in K170398: a new implant line, Tryon Conic HE, with an external hexagon abutment interface; a series of conventional (not CAD-CAM) prosthetic components that are compatible with implants from the S.I.N. Dental Implant System; and a series of CAD-CAM prosthetic components for fabrication of patient-specific restorations that are compatible with implants from the S.I.N. Dental Implant System.