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510(k) Data Aggregation

    K Number
    K081268
    Device Name
    SONIC AIR MM1500 + (MID), MODEL 50400014
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    2009-08-10

    (462 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SONIC AIR MM1500 + (MID), MODEL 50400014

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Endodontics

    canal preparation -

    canal cleaning

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Sonic Air MM 1500+ (MID)" device, indicating that it has been found substantially equivalent to a predicate device for endodontic canal preparation and cleaning.

    The letter discusses regulatory compliance requirements but does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this document.

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