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510(k) Data Aggregation

    K Number
    K022264
    Device Name
    CLEAN 'N' OIL
    Date Cleared
    2002-10-02

    (82 days)

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

    SVENSKA DENTAL INSTRUMENTS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors.
    Device Description
    Not Found
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    K Number
    K022265
    Device Name
    LIGHT TIP
    Date Cleared
    2002-10-02

    (82 days)

    Product Code
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SVENSKA DENTAL INSTRUMENTS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.
    Device Description
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