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The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Alpha-Bio Dental Implant System® consists of one and two stage endosseous form dental implants, internal and external hexagonal; internal octagonal hexagonal; one piece implants system; cover screws and healing caps; abutment systems and superstructures; surgical instruments.

The provided text focuses on regulatory submissions and approvals for the Alpha-Bio Tec® Dental Implant System and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide the requested table and details as the information is not present in the given document. The document primarily identifies the device, its intended use, predicate devices, and regulatory compliance with established standards (like ISO and ASTM) rather than specific performance studies with acceptance criteria.

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