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

    T-FIT

    K Number: K231913 · Decision Feb 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    T-FIT
    K Number
    K231913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techwin Co., Ltd.
    Date Received
    June 29, 2023
    Decision Date
    February 8, 2024
    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 Techwin Co., Ltd.

    K Number Device Name
    K231932 TDS (TECHWIN DENTAL SYSTEM)