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510(k) Data Aggregation

    K Number
    K973289
    Device Name
    RE NU
    Date Cleared
    1999-02-09

    (525 days)

    Product Code
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC RIM DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use by a dental professional for the purpose of cleaning teeth.
    Device Description
    RE NU Prophy Paste
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    K Number
    K972871
    Device Name
    GENESIS
    Date Cleared
    1997-10-02

    (59 days)

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

    PACIFIC RIM DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use by a dental professional in obtaining a reproduction of teeth and investing tissues, as needed.
    Device Description
    Not Found
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