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510(k) Data Aggregation

    K Number
    K022425
    Device Name
    SCREWLINE
    Manufacturer
    ALTATEC BIOTECHNOLOGIES N.A., INC.
    Date Cleared
    2002-08-14

    (21 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTATEC BIOTECHNOLOGIES N.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALTATEC BIOTECHNOLOGIES implants are indicated single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
    Device Description
    Not Found
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