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iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification clearance letter for the iSy® Implant System, which establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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