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

    NEODENT IMPLANT SYSTEM

    K Number: K133696 · Decision Feb 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    11
    Review Days
    84

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    Basic Information

    Device Name
    NEODENT IMPLANT SYSTEM
    K Number
    K133696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jjgc Industria E Comercio DE Materiais Dentarios S
    Date Received
    December 3, 2013
    Decision Date
    February 25, 2014
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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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
    K123022 NEODENT IMPLANT SYSTEM
    K102769 NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
    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 →