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510(k) Data Aggregation

    K Number
    K030605
    Device Name
    RAPID IMF
    Manufacturer
    ZYGOMATICS LTD.
    Date Cleared
    2003-06-27

    (122 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYGOMATICS LTD.

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

    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for:

    • Pre-operative fixation
    • Per-operative fixation
    • Short-term (up to 3 weeks) fixation for minimally displaced fractures
    • Splintage post jaw dislocation
    Device Description

    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a medical device called "RAPID IMF™", stating that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory compliance requirements. It also includes the indications for use of the device.

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