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

    One-Fil Putty Injectable

    K Number: K251884 · Decision Aug 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    13
    Review Days
    63

    Basic Information

    Device Name
    One-Fil Putty Injectable
    K Number
    K251884
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediclus Co., Ltd.
    Date Received
    June 20, 2025
    Decision Date
    August 22, 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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    Other Clearances by Mediclus Co., Ltd.

    K Number Device Name
    K260485 Any-Etch
    K260819 Any-Com Seal
    K253797 One-Stop
    K253167 Any-Paste
    K252465 Any-Core
    K251283 Once-Fil Flow
    K250823 Any-Com Flow
    K243353 One-Fil Putty
    K242713 Any-Com Bulk
    K241147 Any-Com
    Search all 13 clearances from Mediclus Co., Ltd. →