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The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment. This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890).

The provided text describes the regulatory clearance of a dental implant system and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML device. Therefore, the information requested for an AI/ML device, such as specific acceptance criteria and detailed study designs involving test sets, ground truth establishment, and expert involvement, is not available in the provided document.

The document primarily discusses:

• Device: Neodent Implant System - Zirconia Implant System, specifically the Zirconia Base abutment.
• Purpose of Submission: To introduce a conventional workflow for manually designed prostheses using Zirconia Bases and to include a new restoration material (IPS e.max® Press).
• Method of Proof: Substantial Equivalence to legally marketed predicate devices, as per FDA 510(k) requirements. This involves comparing indications for use, technological characteristics, materials, and manufacturing processes, supported by performance data (mechanical testing, MR compatibility, sterilization validation, biocompatibility) demonstrating that the new workflow and material do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested tables and information as it pertains to AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its evaluation.

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