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510(k) Data Aggregation

    K Number
    K110378
    Device Name
    IMPRESSION COMPOUND
    Manufacturer
    SPOFADENTAL
    Date Cleared
    2011-04-05

    (83 days)

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

    SPOFADENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Impression Compound is intended for use as a rebasing and relining impression material as well as for general impressions including, but not limited to dentures, root surfaces and posts.
    Device Description
    Impression Compound is a thermoplastic impression material available in cakes for full or partial impressions or in sticks for adding to the periphery of an impression or for copper band impressions. Impression Compound is available in three different working temperatures. The different colors signify the softening temperature of each compound.
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