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

    VERTEX ETCHANT

    K Number: K010849 · Decision Sep 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    15
    Review Days
    177

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    Basic Information

    Device Name
    VERTEX ETCHANT
    K Number
    K010849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apex Dental Materials, Inc.
    Date Received
    March 21, 2001
    Decision Date
    September 14, 2001
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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