BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Carriere® Motion Pro® Clear Bite Corrector

    K Number: K252760 · Decision Nov 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    41
    Applicant Total
    8
    Review Days
    90

    Basic Information

    Device Name
    Carriere® Motion Pro® Clear Bite Corrector
    K Number
    K252760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Organizers, Inc.
    Date Received
    August 29, 2025
    Decision Date
    November 27, 2025
    Product Code
    DYW
    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
    DYW Bracket, Plastic, Orthodontic

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