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510(k) Data Aggregation

    K Number
    K113575
    Device Name
    HILLA DIGITAL TRANSFERS
    Date Cleared
    2012-03-07

    (96 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HILLA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HILLA DIGITAL TRANSFERS are colored ceramic stains, supplied in a decal form, for firing onto dental ceramic prosthetic devices.
    Device Description
    HILLA DIGITAL TRANSFERS are ceramic stain powders in a decal form, for application to dental ceramic prosthetic devices. The decals are applied and fired on ceramic dental restorations. After firing the decal, what remains is a silicate ceramic stains, which are substantially equivalent to the silicate ceramic stains disclosed in K000983.
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