LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K143591
    Device Name
    Dorsal Appliance
    Manufacturer
    GERGENS ORTHODONTIC LAB
    Date Cleared
    2015-04-15

    (118 days)

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

    GERGENS ORTHODONTIC LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
    Device Description
    The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
    Ask a Question
    K Number
    K113126
    Device Name
    ACRYLIC HERBST APPLIANCE
    Manufacturer
    GERGENS ORTHODONTIC LAB
    Date Cleared
    2013-07-17

    (632 days)

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

    GERGENS ORTHODONTIC LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
    Device Description
    The Acrylic Herbst Appliance is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
    Ask a Question

    Page 1 of 1