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

    PF Keep; Cad Cam Keep Block

    K Number: K233171 · Decision Nov 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    60

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    Basic Information

    Device Name
    PF Keep; Cad Cam Keep Block
    K Number
    K233171
    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 28, 2023
    Decision Date
    November 27, 2023
    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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