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The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant.

Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.

The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.

The provided text is for a 510(k) summary for a dental device, "Inclusive Titanium Abutment Blanks." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details is not available in the provided document.

The 510(k) summary states:

• Substantial Equivalence: The device is substantially equivalent to other legally marketed devices, specifically Nobel Biocare's Branemark (K042658) and NobelActive Internal (K071370) implants, and Institut Straumann's (K062129) implants.
• Safety and Efficacy: "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations."

This indicates that the FDA cleared this device based on its similarity to already approved devices, meaning extensive de novo clinical trials or performance studies with predefined acceptance criteria were likely not required. The focus was on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to its predicates.

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