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The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutments. The abutments will seat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders.

All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG),

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I am sorry, but the provided text from the FDA 510(k) letter for the "UCLA and Cement-On Abutments and Accessories" does not contain the information requested about acceptance criteria or a study proving device performance.

This document is a letter from the FDA confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It states that the device has been reviewed and determined to be substantially equivalent based on the indications for use provided by the applicant.

The letter acknowledges the device's classification and lists general regulatory requirements (registration, labeling, good manufacturing practice, etc.). It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets or data provenance.
• Information on the number or qualifications of experts for ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm-only performance study.
• The type of ground truth used in any study.
• Training set sample sizes or how their ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is focused on regulatory clearance based on substantial equivalence, not on detailed performance study reports.

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• . Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw.
• Impression Posts are used to register the location and position of the implants in mouth.
• Implant Analogs are replicas of the implants and are mounted in stone model.
• . Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement.
• Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement.
• Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting.

All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.

UCLA/Universal Abutments, Impression Posts, Implant Analogs, Cement Retained Abutments, Temporary Abutments, Tools, and Accessories.

This document is an FDA 510(k) clearance letter for dental abutments and related accessories. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical study report or a performance validation report would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory clearance, determining substantial equivalence to a predicate device, and outlining the intended uses of the device.

To provide the requested information, a different type of document, such as a "Summary of Safety and Effectiveness" (which often accompanies a 510(k) submission) or a study report, would be needed.

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