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510(k) Data Aggregation

    K Number
    K000846
    Device Name
    TKD SCALERS
    Manufacturer
    Date Cleared
    2000-12-04

    (264 days)

    Product Code
    Regulation Number
    872.4850
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    Applicant Name (Manufacturer) :

    ORASYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000848
    Device Name
    TDK HANDPIECES
    Manufacturer
    Date Cleared
    2000-10-05

    (204 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORASYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000847
    Device Name
    ORALUBE
    Manufacturer
    Date Cleared
    2000-09-27

    (196 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORASYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

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