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The Zimmer Dental Hex-Lock Prepared Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental Hex-Lock Prepared Angled Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Either abutment can be used for a single or multiple-unit restoration.

The 'Prepared' Abutment is a titanium alloy post with a tapered cone, predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.

The 'Prepared' Angled Abutment is a titanium alloy post with the cone offset by 17°, a predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.

The provided text is a 510(k) summary for a dental device called "Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)". It describes the device, its intended use, and comparison to a predicate device. However, it does not contain any information about acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information from the given text. This document is a regulatory submission for substantial equivalence based on device modification, not a performance study report.

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