BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

    K Number: K231696 · Decision Aug 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    418
    Applicant Total
    7
    Review Days
    60

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    Basic Information

    Device Name
    Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
    K Number
    K231696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prevest Denpro Limited
    Date Received
    June 12, 2023
    Decision Date
    August 11, 2023
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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