BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇳🇱 Netherlands

    NextDent Ortho Flex

    K Number: K221022 · Decision Oct 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    8
    Review Days
    198

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    Basic Information

    Device Name
    NextDent Ortho Flex
    K Number
    K221022
    Device Class
    FDA unclassified
    Clearance Type
    Abbreviated
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertex-Dental B.V.
    Date Received
    April 6, 2022
    Decision Date
    October 21, 2022
    Product Code
    MQC
    Advisory Committee
    Unknown
    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
    MQC Mouthguard, Prescription

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    Other Clearances by Vertex-Dental B.V.

    K Number Device Name
    K241071 NextDent Jet Denture Base; NextDent Jet Denture Teeth
    K231388 NextDent Base
    K191497 NextDent Denture 3D+
    K162572 NextDent Denture, E-Denture
    K123220 VERTEX THERMOSENS RIGID
    K102640 VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
    K102654 VERTEX RAPID SIMPLIFIED