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510(k) Data Aggregation

    K Number
    K091035
    Device Name
    FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
    Manufacturer
    BRYAN KEROPIAN DDS
    Date Cleared
    2009-06-24

    (75 days)

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

    BRYAN KEROPIAN DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring. 2. Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
    Device Description
    The Full Breath Soution Lower is a custom fabricated device which is typically done by a professional dental laboratory and delivered by a dentist.
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    K Number
    K061228
    Device Name
    FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
    Manufacturer
    BRYAN KEROPIAN DDS
    Date Cleared
    2006-05-26

    (24 days)

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

    BRYAN KEROPIAN DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring. 2. Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
    Device Description
    Not Found
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    K Number
    K053065
    Device Name
    FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
    Manufacturer
    BRYAN KEROPIAN DDS
    Date Cleared
    2006-01-03

    (63 days)

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

    BRYAN KEROPIAN DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea. 2. For the treatment of snoring. 3. For the prevention of bruxism.
    Device Description
    The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.
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    K Number
    K052862
    Device Name
    FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
    Manufacturer
    BRYAN KEROPIAN DDS
    Date Cleared
    2005-12-30

    (80 days)

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

    BRYAN KEROPIAN DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA 2) For the treatment of SNORING 3) For the prevENTION OF DRUKIEM.
    Device Description
    The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.
    Ask a Question

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