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510(k) Data Aggregation

    K Number
    K022535
    Device Name
    MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
    Manufacturer
    MICROTECH
    Date Cleared
    2002-10-22

    (83 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K063110
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This handpiece is to be used for intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.

    Device Description

    Microtech Push Button Handpiece

    AI/ML Overview

    The provided text is a government letter from the FDA regarding the clearance of a medical device, the "Microtech Push Button Handpiece." It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    The letter is a 510(k) premarket notification acceptance, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to existing devices rather than new performance studies against specific acceptance criteria.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving their fulfillment based on this document. The document primarily focuses on regulatory approval and classification.

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