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

    Bioceramic Root Repair Material (C-Root BP)

    K Number: K240365 · Decision May 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    Bioceramic Root Repair Material (C-Root BP)
    K Number
    K240365
    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
    February 6, 2024
    Decision Date
    May 10, 2024
    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.

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