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510(k) Data Aggregation

    K Number
    K051910
    Device Name
    MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
    Manufacturer
    D.B.I. AMERICA CORP.
    Date Cleared
    2005-09-02

    (50 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    D.B.I. AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrasonic Scaler is intended to be used by a dental hygienist for use during dental cleaning to remove calculus deposits from the teeth.
    Device Description
    Not Found
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    K Number
    K981990
    Device Name
    MRS-400, MAXI 400, MRSL-400, MAXI 400L
    Manufacturer
    D.B.I. AMERICA CORP.
    Date Cleared
    1998-06-22

    (14 days)

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

    D.B.I. AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.
    Device Description
    Dental Handpiece and Accessories (21 CFR 872.4200)
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