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    FDA 510(k) FDA class 1 Substantially Equivalent 🇧🇷 Brazil

    Infinity / Infinity Cross Flex Dental Systems

    K Number: K180935 · Decision Feb 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    1
    Review Days
    666

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    Basic Information

    Device Name
    Infinity / Infinity Cross Flex Dental Systems
    K Number
    K180935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Olsen Industria E Comercio S.A.
    Date Received
    April 10, 2018
    Decision Date
    February 5, 2020
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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