Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191033
    Device Name
    LunaGuard Nighttime Dental Protector
    Manufacturer
    Date Cleared
    2019-08-05

    (109 days)

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

    McKeon Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
    Device Description
    The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism. When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing. The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1