Search Results

Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.

Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

The provided text is a 510(k) summary for the Nobel Biocare Procera Bridge Zirconia device. It primarily focuses on the device description, indications for use, and regulatory classification, stating its substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies. The 510(k) process for this type of device (a Class II Porcelain Tooth) largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than on generating new clinical performance data with specific acceptance criteria.

Therefore, for your request, I must report that the requested information is not available within the provided text. The document is a regulatory submission for premarket notification, not a performance study report.

Ask a specific question about this device