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

    VSP System (Titanium Palatal Splint)

    K Number: K261826 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    31
    Applicant Total
    12
    Review Days
    2

    Basic Information

    Device Name
    VSP System (Titanium Palatal Splint)
    K Number
    K261826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Systems, Inc.
    Date Received
    June 1, 2026
    Decision Date
    June 3, 2026
    Product Code
    DZJ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZJ Driver, Wire, And Bone Drill, Manual

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