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

    VERTEX SEALAND L/C ORTHODONTIC SEALANT

    K Number: K010547 · Decision Aug 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    410
    Applicant Total
    13
    Review Days
    174

    Basic Information

    Device Name
    VERTEX SEALAND L/C ORTHODONTIC SEALANT
    K Number
    K010547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    APEX DENTAL MATERIALS, INC.
    Date Received
    February 23, 2001
    Decision Date
    August 16, 2001
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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