BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    SURGmatic S15 L Pro

    K Number: K213139 · Decision Dec 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    SURGmatic S15 L Pro
    K Number
    K213139
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kavo Dental GmbH
    Date Received
    September 27, 2021
    Decision Date
    December 21, 2021
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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