BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Injectable Root Canal Bioceramic Sealer

    K Number: K212983 · Decision Dec 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    Injectable Root Canal Bioceramic Sealer
    K Number
    K212983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing C-Root Dental Medical Devices Co., Ltd.
    Date Received
    September 17, 2021
    Decision Date
    December 8, 2021
    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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    Other Clearances by Beijing C-Root Dental Medical Devices Co., Ltd.

    K Number Device Name
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