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510(k) Data Aggregation

    K Number
    K032925
    Device Name
    B&R DEVICE
    Manufacturer
    RONVIG A/S
    Date Cleared
    2003-12-22

    (91 days)

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

    RONVIG A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The B&R device is a contra-angle intended for dental implant surgery i.e. drilling procedures prior to the placement of implant prosthetics in the jaw bone.
    Device Description
    The B&R device is a contra-angle.
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    K Number
    K010816
    Device Name
    DENTO-PREP PARTICLE MICROBLASTER
    Manufacturer
    RONVIG A/S
    Date Cleared
    2001-05-10

    (52 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    RONVIG A/S

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