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Found 4 results

510(k) Data Aggregation

    K Number
    K020062
    Device Name
    XERAFIT
    Date Cleared
    2002-02-14

    (37 days)

    Product Code
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    METALOR TECHNOLOGIES USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Porcelain - to - metal restorations
    Device Description
    Not Found
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    K Number
    K013769
    Device Name
    V-GNATHOS SUPRA
    Date Cleared
    2002-01-22

    (70 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    METALOR TECHNOLOGIES USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works.
    Device Description
    Not Found
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    K Number
    K013506
    Device Name
    YELLOW SPECIAL
    Date Cleared
    2002-01-03

    (73 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    METALOR TECHNOLOGIES USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.
    Device Description
    Not Found
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    K Number
    K013505
    Device Name
    AUROFLUID PLUS
    Date Cleared
    2001-12-19

    (58 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    METALOR TECHNOLOGIES USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Low fusing ceramic crowns, small bridges, inlays, onlays
    Device Description
    Not Found
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