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510(k) Data Aggregation

    K Number
    K171772
    Device Name
    Ecosite Bulk Fill
    Manufacturer
    DMG USA Inc.
    Date Cleared
    2018-01-31

    (231 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG USA Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Restorations in the posterior region (Classes I and II, including replacement of individual cusps) - Restorations of class V (cervical caries, root erosions, wedge-shaped defects) - Core build-up - Restorations in deciduous teeth
    Device Description
    Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.
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