BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ProTech Plus

    K Number: K151646 · Decision Oct 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    ProTech Plus
    K Number
    K151646
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Protech Professional Products, Inc.
    Date Received
    June 18, 2015
    Decision Date
    October 21, 2015
    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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    Other Clearances by Protech Professional Products, Inc.

    K Number Device Name
    K925062 PERMAFLEX PERMANENT SOFT DENTURE RELINER