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510(k) Data Aggregation

    K Number
    K150492
    Device Name
    Ora-GUARD Dental Grind Guard
    Manufacturer
    Bite Tech Inc.
    Date Cleared
    2016-02-19

    (359 days)

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

    Bite Tech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ora-GUARD Dental Grind Guard is a device that is indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching. It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.
    Device Description
    Ora-GUARD Dental Grind Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The Ora-GUARD Dental Grind Guard is intended to be worn while sleeping (e.g., at night or while napping). The material is comfortable to wear, and it can be self-fit by submerging in hot water to make the material malleable to fit on the lower teeth of the oral cavity. Ora-GUARD Dental Grind Guard is constructed of a soft EVA, which contacts the tooth surface and a hard base, which protects bite-through by user when bruxing (polycarbonate). Ora-GUARD Dental Grind Guard is provided in one size that fits most (comfortably fits palate sizes ranging from two to two and one half inches wide).
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