LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K124008
    Device Name
    IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
    Manufacturer
    IVOCLAR VIVADENT, AGIN
    Date Cleared
    2013-03-29

    (92 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR VIVADENT, AGIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations. IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of: - Hybrid abutments for single-tooth restorations - - -Hybrid abutment crowns for restorations
    Device Description
    IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.
    Ask a Question

    Page 1 of 1