BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇽 Mexico

    Partial Flex

    K Number: K242897 · Decision Jun 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    Partial Flex
    K Number
    K242897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clemde SA DE CV
    Date Received
    September 23, 2024
    Decision Date
    June 3, 2025
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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