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Nobel Biocare's Procera Copings and Pontic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.

The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.

The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.

Nobel Biocare's Procera® Copings and Pontic are prefabricated devices intended for use as core structures of prosthetic devices, such as three-unit bridges. The Copings are also intended for use as the core structure of single crowns.

Nobel Biocare's Procera* Copings are used with the Pontic in a three-unit bridge. The Coping serves as the core structure of the two side crowns, while the Pontic serves as the core structure of the center unit in the three-unit bridge.

Nobel Biocare's Procera" Copings are also the core structure of a single crown that can be placed on both a natural or artificial tooth abutment.

Nobel Biocare's Procera* Copings and Pontic are manufactured from either Aluminum Oxide powder or Zirconium Oxide powder. The ceramic materials (both Aluminum Oxide and Zirconium Oxide) enhance the esthetics of the restoration by giving the teeth a natural appearance.

This document describes a 510(k) premarket notification for the Nobel Biocare Procera Copings and Pontic. It does not contain information about a study that assesses acceptance criteria in the context of device performance metrics typically found in AI/ML medical device submissions.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them with information like sample sizes, ground truth establishment, or expert qualifications. This document focuses on the regulatory clearance process for a dental prosthetic device based on substantial equivalence to predicate devices, not on a performance study comparing the device to specific acceptance criteria.

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