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

    Any-Paste

    K Number: K253167 · Decision Jan 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    13
    Review Days
    108

    Basic Information

    Device Name
    Any-Paste
    K Number
    K253167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediclus Co., Ltd.
    Date Received
    September 26, 2025
    Decision Date
    January 12, 2026
    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.

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    K251283 Once-Fil Flow
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