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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 WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text describes a 510(k) premarket notification for a dental abutment, not a study evaluating a device's performance against acceptance criteria using AI or advanced analytical methods. Therefore, I cannot extract the requested information as it is not present in the given document.

The document focuses on:

• Device Identification: Straumann WN CARES Titanium Abutment.
• Intended Use: To support prosthetic restorations (crowns, bridges) in dental implants for single or multiple tooth replacements.
• Predicate Device: RN CARES Titanium Abutment (K052272).
• Substantial Equivalence Claim: The new device is substantially equivalent to the predicate device in material composition, design, and operating principles.
• Regulatory Classification: Class II under 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
• FDA Clearance: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

There is no mention of acceptance criteria, a study proving device performance, sample sizes for test or training sets, ground truth establishment, expert adjudication, or any AI or MRMC comparative effectiveness study.

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