BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Black Diamond

    K Number: K222323 · Decision Jun 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    325

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    Basic Information

    Device Name
    Black Diamond
    K Number
    K222323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elevate Oral Care, LLC
    Date Received
    August 2, 2022
    Decision Date
    June 23, 2023
    Product Code
    PHR
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

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