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The Zimmer Dental One Piece Tapered Abutment is intended for use in multiple unit screw retained restorations.

The Tapered Abutment is a titanium alloy post with a tapered cone. The abutments are utilized in multi unit configurations with a screw retained bridge threaded directly into them. The new Abutment features a .75mm cuff height.

I am sorry, but based on the provided text, there is no information about a study that assesses the performance of a device against acceptance criteria using objective metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) premarket notification for a Zimmer Dental Tapered Abutment. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and materials. It does not describe an AI/ML device or a clinical study that would involve acceptance criteria for reported device performance in the way you've outlined.

The text includes:

• Device Description: The Zimmer Dental Tapered Abutment is a titanium alloy post with a tapered cone, used in multi-unit configurations with a screw-retained bridge. The modification is a new abutment with a 0.75mm cuff height.
• Intended Use: For screw-retained dentures, screw-retained partial dentures, and bar overdenture restorations.
• Device Comparison: The new abutment is compared to existing Zimmer Dental Tapered Abutments (with a 2.0mm cuff height) and Hex-Lock Abutments, emphasizing similar intended use and design, with the primary difference being the cuff height for the Tapered Abutment and unit configuration for the Hex-Lock Abutment.
• FDA Clearance: The document is an FDA 510(k) clearance letter confirming substantial equivalence to predicate devices.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as that information is not present in the provided text.

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