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510(k) Data Aggregation

    K Number
    K060744
    Device Name
    O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
    Date Cleared
    2006-06-02

    (74 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    O'BRIEN DENTAL LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.
    Device Description
    The O'Brien MPA is made of thermal plastic material (ADA approved materials). It is a very simple device that fits snugly over the upper and lower anterior teeth in such a way as to keep the mandible in a stationary, anterior protrusive position. The reason for this is to physically open the airway and thus potentially reduce the occurrence of snoring and sleep apnea. (This theory of airway management is common, standard operating procedures in the emergency medical field for airway management purposes.) The device also includes air channels to allow breathing through the mouth.
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