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

    HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)

    K Number: K132937 · Decision May 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    5
    Review Days
    245

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    Basic Information

    Device Name
    HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
    K Number
    K132937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harvest Dental Products, LLC
    Date Received
    September 18, 2013
    Decision Date
    May 21, 2014
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Harvest Dental Products, LLC

    K Number Device Name
    K231389 Harvest Dental HD Gum Strip
    K222961 Harvest Conceal ZR Block Out
    K222489 Harvest Printable Resin
    K180578 Harvest Dental Polymer Blocks