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510(k) Data Aggregation

    K Number
    K222323
    Device Name
    Black Diamond
    Manufacturer
    Elevate Oral Care, LLC
    Date Cleared
    2023-06-23

    (325 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elevate Oral Care, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
    Device Description
    Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity. The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
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