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Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) Summary for the Straumann Guided Instruments Drill Bits. It describes the device, its intended use, and its equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as it is a summary for a new version of an already-approved device, stating technological equivalence to a predicate device.

The 510(k) summary explicitly states:

• "The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices."
• "The intended use is identical to the predicate devices."
• "The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices."

Since this submission establishes substantial equivalence to a predicate device based on similar design, material, and intended use, a new clinical performance study with acceptance criteria, expert adjudication, or MRMC studies is typically not required or presented in a 510(k) summary for this type of device. The focus is on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the already cleared predicate.

Therefore, I cannot populate the requested table and answer the specific questions because the provided text does not contain the necessary information.

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