BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Neodent Implant System- CM Drive Implants

    K Number: K150182 · Decision Apr 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    11
    Review Days
    86

    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
    Neodent Implant System- CM Drive Implants
    K Number
    K150182
    Device Class
    FDA class 2
    Clearance Type
    Special
    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
    January 27, 2015
    Decision Date
    April 23, 2015
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

    Similar 510(k) Clearances

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

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

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

    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
    K133696 NEODENT IMPLANT SYSTEM
    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 →