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

    BOSS

    K Number: K253723 · Decision Jun 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    204

    Basic Information

    Device Name
    BOSS
    K Number
    K253723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medpark Co., Ltd.
    Date Received
    November 24, 2025
    Decision Date
    June 16, 2026
    Product Code
    NPM
    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
    NPM Bone Grafting Material, Animal Source

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