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The Tapered SwissPlus® Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered SwissPlus® implant is an endosseous dental implant designed for single stage placement. The implant is composed of pure titanium or titanium allov. The implant is tapered with double-lead threads. The new device will feature hydroxylapatite coating, hydroxylapatite coating with additional Zimmer Dental MP-1® processing, or MTX surface equivalent to existing Zimmer Dental implants.

The provided text describes a 510(k) premarket notification for the "Tapered SwissPlus® Implant" and discusses its substantial equivalence to predicate devices. However, the document does not contain information typically found in a study proving a device meets specific performance acceptance criteria. It primarily focuses on regulatory approval and substantial equivalence based on design and materials, rather than a clinical or performance study with defined acceptance criteria and results.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not a performance study.

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