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

    Additively Manufactured Aligner Resin

    K Number: K251415 · Decision Aug 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    16
    Review Days
    112

    Basic Information

    Device Name
    Additively Manufactured Aligner Resin
    K Number
    K251415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Received
    May 7, 2025
    Decision Date
    August 27, 2025
    Product Code
    NXC
    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
    NXC Aligner, Sequential

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