(116 days)
The NobelProcera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Nobel Biocare's NobelProcera Implant Bridge is a bridge framework that attaches to implants or abutments. The NobelProcera Implant Bridge is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
NobelProcera Implant Bridges are made individually following instructions and models specific to each patient. The NobelProcera Implant Bridge is made entirely of titanium.
This document is a 510(k) summary for the NobelProcera Implant Bridge, a dental device. It outlines the device description, indications for use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot provide the requested table and information based solely on the provided text. The provided text is a regulatory submission for premarket notification, which focuses on device description and substantial equivalence, not detailed performance studies or clinical trial results.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)