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

    SD TL Implant System

    K Number: K250280 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    17
    Review Days
    173

    Basic Information

    Device Name
    SD TL Implant System
    K Number
    K250280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arum Dentistry Co., Ltd.
    Date Received
    January 31, 2025
    Decision Date
    July 23, 2025
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Arum Dentistry Co., Ltd.

    K Number Device Name
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    K232559 C&B NFH Hybrid
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