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

    Injectable Root Canal Bioceramic Sealer (nRoot SP)

    K Number: K250710 · Decision Jun 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    1
    Review Days
    93

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    Basic Information

    Device Name
    Injectable Root Canal Bioceramic Sealer (nRoot SP)
    K Number
    K250710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enpuno Co., Ltd.
    Date Received
    March 10, 2025
    Decision Date
    June 11, 2025
    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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