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Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.

The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

The previously cleared Straumann CARES Titanium Abutments are placed onto dental implants to support prosthetic reconstructions such as crowns and bridges. The abutment allows for individual customization regarding function and esthetics. The design step is typically performed by the dental laboratory to the specifications from a clinician. The abutments are produced by a Straumann Manufacturing milling center.

The patient-specific abutment is designed by a traditional waxup and subsequent scanning or by scanning of the intraoral setting and designing the element via CAD software. The design information is sent via an Internet portal to Straumann. Straumann verifies the design against the validated design parameters. These design limits include a maximum angulation of 30° and a minimum surface area as follows:

Tooth Position, Minimum surface area mm²
7,10, 24,25, 37
4,5,12,13,20,21,28,29, 47
26,11,2,27,8,9, 43
1-3, 14-16, 17-19,30-32, 56

The abutments are manufactured from solid grade 4 titanium at the Straumann milling center. The abutment is delivered to the dental laboratory for final processing before delivery to the clinician. The abutments are attached to the implant with a titanium alloy basal screw. The occlusal restoration is affixed to the titanium abutment using dental cement.

The proposed devices are a modification of the previously licensed devices. The titanium abutments that serve as the base of the CARES Golden Ti/TiN Abutments (the uncoated abutments) are identical in every respect to the reference devices. The modification consists of the addition of a titanium nitride (TiN) coating on the emergence profile and coronal aspect of the abutment. The apical portion of the abutment consisting of the implant-to-abutment interface is masked during the coating process to assure that the interface remains uncoated.

The provided text describes the Straumann® CARES® Golden Ti/TiN Abutments, a dental device, and its substantial equivalence to predicate devices. It outlines the design, materials, and performance data used to support its clearance.

However, the document is a 510(k) summary for a medical device and therefore, it does not contain information about an AI/ML powered device, a study proving the device meets specific acceptance criteria related to AI/ML performance, or details about ground truth, expert consensus, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to an AI/ML device, nor can I provide information on sample sizes for test/training sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.

The document focuses on demonstrating substantial equivalence based on material, design, indications for use, and a series of standard performance tests for dental abutments.

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