BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CeraSeal

    K Number: K190503 · Decision Jun 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    137
    Applicant Total
    7
    Review Days
    98

    Basic Information

    Device Name
    CeraSeal
    K Number
    K190503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meta Biomed Co., Ltd.
    Date Received
    March 1, 2019
    Decision Date
    June 7, 2019
    Product Code
    KIF
    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
    KIF Resin, Root Canal Filling

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