BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE

    K Number: K102769 · Decision Feb 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    11
    Review Days
    152

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    Basic Information

    Device Name
    NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
    K Number
    K102769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jjgc Industria E Comercio DE Materiais Dentarios S
    Date Received
    September 24, 2010
    Decision Date
    February 23, 2011
    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 Jjgc Industria E Comercio DE Materiais Dentarios S

    K Number Device Name
    K153624 Neodent Implant System
    K141777 NEODENT IMPLANT SYSTEM
    K150367 Neodent Implant System
    K150199 Neodent Implant System
    K150182 Neodent Implant System- CM Drive Implants
    K133696 NEODENT IMPLANT SYSTEM
    K123022 NEODENT IMPLANT SYSTEM
    K103084 NEODENT GRAFT SCREW
    K101945 NEODENT IMPLANT SYSTEM
    K101207 NEODENT IMPLANT SYSTEM
    Search all 11 clearances from Jjgc Industria E Comercio DE Materiais Dentarios S →