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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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)

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece and accessories, dated June 22, 1998. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document.

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