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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Luna Dental Implant System- Healing Abutment

    K Number: K200189 · Decision Feb 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    Luna Dental Implant System- Healing Abutment
    K Number
    K200189
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shinhung Mst Co., Ltd.
    Date Received
    January 27, 2020
    Decision Date
    February 26, 2020
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Shinhung Mst Co., Ltd.

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