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

    SYNTEC WETALI ORTHODONTIC MINI SCREWS

    K Number: K142001 · Decision Mar 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    238

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    Basic Information

    Device Name
    SYNTEC WETALI ORTHODONTIC MINI SCREWS
    K Number
    K142001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntec Scientific Corporation - Taipei Office
    Date Received
    July 23, 2014
    Decision Date
    March 18, 2015
    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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