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Nobel Biocare's Esthetic Zirconia Abutment is indicated for the treatment of partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function.

Nobel Biocare's Esthetic Zirconia Abutment incorporates a material change to the predicate device, Ceramic Abutment (K913255). The intended use of the modified Esthetic Zirconia Abutment, as described in its labeling, has not changed from the unmodified device, Ceramic Abutment (K913255), as a result of this modification. Like the original device, Ceramic Abutment (K913255), the Esthetic Zirconia Abutment is intended for use as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

The material change consists of using Zirconium Oxide, rather than Aluminum Oxide, in the manufacturing of the device. In order to improve esthetics, a whiter prosthetic device is desired within the dental industry. To achieve this, Nobel Biocare's Esthetic Zirconia Abutment will be manufactured using Zirconium Oxide powder, rather than Aluminum Oxide powder utilized in the predicate device, Ceramic Abutment (K913255).

The FDA previously deared the Zirconium Oxide powder (trade name: Y-TZP Powder) under 510(k) number K010630.

The provided text describes a 510(k) summary for the "Esthetic Zirconia Abutment" by Nobel Biocare AB. This document focuses on demonstrating substantial equivalence to a predicate device, primarily due to a material change. It does not contain information typically found in acceptance criteria or study reports for an AI/ML device performance evaluation. The device is a physical dental implant component, not a software or AI device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth," "MRMC study," "standalone performance," and "training set" are not applicable to the evaluation of this physical dental abutment.

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