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510(k) Data Aggregation

    K Number
    K081273
    Device Name
    ULTRACAPS S
    Manufacturer
    SDI LTD.
    Date Cleared
    2008-07-10

    (66 days)

    Product Code
    OIV, EJJ, ELY
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SDI LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for tooth restorations as a treatment for dental carries and for interious for tooth restorations (Class I and Class II), when other materials or restoration techniques are not indicated. For professional use only.
    Device Description
    Not Found
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    K Number
    K073043
    Device Name
    SET PP
    Manufacturer
    SDI LTD.
    Date Cleared
    2007-12-14

    (46 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SDI LTD.

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

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