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510(k) Data Aggregation

    K Number
    K062176
    Device Name
    RELIEF ACP ORAL CARE GEL
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2007-01-10

    (163 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RELIEF ACP ORAL CARE GEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.

    Device Description

    Relief ACP Oral Care Gel

    AI/ML Overview

    I am sorry, but I lack the ability to provide you with an answer to your request. The document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA 510(k) clearance letter for a dental product, primarily focusing on its regulatory status and intended use.

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