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510(k) Data Aggregation

    K Number
    K091904
    Device Name
    NOBELPROCERA ZI ABUTMENT
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2009-09-25

    (92 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K042658,K090064
    Predicate For
    K132125,K132881,K212125
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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.

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