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

    Syntec Orthodontic Mini Screw Extended System

    K Number: K202790 · Decision Sep 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    6
    Review Days
    360

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Syntec Orthodontic Mini Screw Extended System
    K Number
    K202790
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntec Scientific Corporation
    Date Received
    September 22, 2020
    Decision Date
    September 17, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OAT), ordered by most recent decision date.

    OrthoEasy Pal; OrthoEasy Pal Long Neck

    FDA 510(k)
    FDA Class 2 ·Dental

    Leone Orthodontic Implant TAD (Temporary Anchorage Device)

    FDA 510(k)
    FDA Class 2 ·Dental

    Mini Screws

    FDA 510(k)
    FDA Class 2 ·Dental

    T-FIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ACR Screw System

    FDA 510(k)
    FDA Class 2 ·Dental

    Mico One Orthodontic Screw

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Syntec Scientific Corporation

    K Number Device Name
    K202935 Syntec Femoral Nail Extended System
    K200933 Syntec Non-Sterile Steinmann Pins System
    K191617 Syntec Tibial Nail System
    K181296 Syntec Femoral Nail System
    K161327 SYNTEC HUMERAL NAIL SYSTEM