(92 days)
The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's NobelProcera Zi Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Zi Abutment attaches directly to endosseous dental implants and provides a platform for restoration.
Nobel Biccare's NobelProcera ZI Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study designs (such as sample sizes, data provenance, expert qualifications, or adjudication methods), or any details regarding a comparative effectiveness study or standalone algorithm performance. The document appears to be a 510(k) summary for a dental implant abutment, primarily focusing on its regulatory classification and indications for use, rather than a performance study report. Therefore, I cannot fulfill your request based on the given input.
§ 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.)