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510(k) Data Aggregation

    K Number
    K971284
    Device Name
    OPALDAM
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    1997-06-03

    (57 days)

    Product Code
    EIG
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) "power" bleaching agent.
    Device Description
    OpalDam resin
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