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510(k) Data Aggregation

    K Number
    K053018
    Device Name
    POLY SILOXANE IMPRESSION MATERIAL
    Manufacturer
    MILLENNIUM DENTAL INTERNATIONAL, INC.
    Date Cleared
    2005-11-08

    (13 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM DENTAL INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
    Device Description
    Multiple (POLY SILOXANE IMPRESSION MATERIAL)
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