BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ZX-27

    K Number: K133088 · Decision Jan 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    459

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    Basic Information

    Device Name
    ZX-27
    K Number
    K133088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3130
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    M&M Dental Studio, Inc.
    Date Received
    September 30, 2013
    Decision Date
    January 2, 2015
    Product Code
    EJX
    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
    EJX Anchor, Preformed