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510(k) Data Aggregation

    K Number
    K971350
    Device Name
    SERIES XE, SERIES SE, SERIES TE
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1997-06-04

    (55 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERIES XE, SERIES SE, SERIES TE

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

    These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964.

    The speed of the motors may not exceed 40 000 RPM.

    These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797.

    They allow to carry out all low speed dental works

    Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to MICRO-MEGA SA regarding their Series XE, SE, and TE contra-angles. It acknowledges that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about:

    • Acceptance criteria or reported device performance for these contra-angles.
    • Any study, clinical or otherwise, that proves the device meets specific acceptance criteria.
    • Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    This letter is a regulatory approval document based on substantial equivalence, not a detailed study report. Therefore, I cannot extract the requested information from the provided text.

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