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510(k) Data Aggregation

    K Number
    K063148
    Device Name
    SOCK IT! ORAL PAIN GEL
    Manufacturer
    MERLIN GROUP DBA MCMERLIN DENTAL COMPANY
    Date Cleared
    2007-01-17

    (93 days)

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

    MERLIN GROUP DBA MCMERLIN DENTAL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Examples of oral lesions include canker sores (aphthous ulcers), tooth extraction sites, oral mucositis, oral stomatic ulcers such is caused by braces and dentures, and irritation and pain following deep tooth scaling.
    Device Description
    "Sock It!" Oral Pain Gel is a clear, viscous hydrogel wound dressing composed entirely of foodgrade ingredients including a food-grade preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and will manage the pain associated with all types of injuries to the mouth. The gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. The pH and osmotic pressure of the gel are adjusted to be compatible with saliva.
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