BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    OBS Anchorage Screw, Biokey Anchorage Screw

    K Number: K202278 · Decision Jan 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    150

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    Basic Information

    Device Name
    OBS Anchorage Screw, Biokey Anchorage Screw
    K Number
    K202278
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bomei Co, Ltd.
    Date Received
    August 11, 2020
    Decision Date
    January 8, 2021
    Product Code
    OAT
    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
    OAT Implant, Endosseous, Orthodontic

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    Other Clearances by Bomei Co, Ltd.

    K Number Device Name
    K152297 OBS Anchorage Screw