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

    SURGICAL VITEX

    K Number: K862926 · Decision Aug 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    25
    Review Days
    28

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    Basic Information

    Device Name
    SURGICAL VITEX
    K Number
    K862926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3645
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Jeneric Ind.
    Date Received
    August 1, 1986
    Decision Date
    August 29, 1986
    Product Code
    ELE
    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
    ELE Implant, Subperiosteal

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