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The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Attachment of prosthetic components to one another and to implants can be achieved with screw fasteming systems. The attachment is secured by the application of torque to the screw. Screws used to fasten the prosthetic components can sometimes loosen. The greater the preload that is applied. the less chance there is that the screw will eventually become loose. Titanium screws that have been "tiodized" can be preloaded to a much greater torque than untreated prosthetic component screws and thus are less likely to loosen. Tiodized® screws are manufactured in diameters (across the head) ranging from 0.086 to 0.106 inches and lengths ranging from 0.160 to 0.576 inches and are composed of titanium alloy that has been subjected to a proprietary anodization process. The screws are slotted or are internally or externally hexed for acceptance of driving tools such as screw drivers, hex drivers and wrenches. Tiodized screws are provided sterile, and are packaged either individually or in sets of up to 6 screws. Tiodized® screws may also be packaged with dental implants or dental implant prosthetic components.

The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria. The document is a 510(k) summary for a "Tiodized® Screw," and it focuses on device description, intended use, and comparison to a predicate device for demonstrating substantial equivalence.

Specifically, the "Performance Data" section explicitly states "Not applicable." This indicates that the submission does not include preclinical or clinical performance data, acceptance criteria, or a study to demonstrate performance against such criteria.

Therefore, I cannot provide the requested information.

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