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

    VERTEX THERMOSENS RIGID

    K Number: K123220 · Decision Mar 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    8
    Review Days
    137

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    Basic Information

    Device Name
    VERTEX THERMOSENS RIGID
    K Number
    K123220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertex-Dental B.V.
    Date Received
    October 15, 2012
    Decision Date
    March 1, 2013
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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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
    K221022 NextDent Ortho Flex
    K191497 NextDent Denture 3D+
    K162572 NextDent Denture, E-Denture
    K102640 VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
    K102654 VERTEX RAPID SIMPLIFIED