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

    EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC

    K Number: K103699 · Decision Aug 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    14
    Applicant Total
    186
    Review Days
    235

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    Basic Information

    Device Name
    EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
    K Number
    K103699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exactech, Inc.
    Date Received
    December 20, 2010
    Decision Date
    August 12, 2011
    Product Code
    NUN
    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
    NUN Bone Grafting Material, Human Source

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