BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DENTAL PLAQUE DISCLOSING AGENT

    K Number: K770990 · Decision Jun 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    DENTAL PLAQUE DISCLOSING AGENT
    K Number
    K770990
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Evident Dental Co. , Ltd.
    Date Received
    May 31, 1977
    Decision Date
    June 20, 1977
    Product Code
    QJC
    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
    QJC Plaque Disclosing Agent