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BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure. These implants are not indicated for immediate loading. These implants are not indicated to support removable resilient retained restorations or angled abutments.

The BTI Dental Implant 5.5-6.5 is a self tapping, threaded dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5

The provided text is a 510(k) summary for a dental implant device (K091387) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding the testing and validation of the device.

The 510(k) summary primarily focuses on:

• Device Description: Self-tapping, threaded dental implant made of titanium for restoring missing teeth.
• Intended Use: Restore missing teeth in partially or fully edentulous patients, or for fixation of overdentures.
• Substantial Equivalence: Compares the device to previously cleared predicate devices (K022258, K053355, K063779).
• Technological Aspects: States that the device is substantially equivalent to predicates in terms of features and intended use.

The FDA letter confirms the clearance of the device based on substantial equivalence and outlines regulatory requirements.

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the given text.

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