(15 days)
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 two, three, or four units and are cemented to natural or artificial tooth abulments.
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 may be two, three, or four units and is precision milled. The Procera® Bridge Zirconia can be cemented or bonded to either natural or artificial tooth aburtments it is personalized according to the specific dimensions of the patient's abutments so the bridge precisely fits, and properly functions, in the patient's jaw.
Nobel Biocare's Procera® Bridge Zirconia is manufactured from one solid piece of densely sintered zirconia.
The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for a dental device (Procera® Bridge Zirconia), primarily focused on regulatory submission details, device description, and indications for use. It states "No special guidance documents, relative to this device, were found," regarding performance standards, implying that specific quantitative acceptance criteria or a dedicated performance study as typically understood in a medical device context are not detailed in this submission.
Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the input text.
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.