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

    NEW TRIAD TRANSHEET DENTURE BASE MATERIAL

    K Number: K905702 · Decision Apr 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    279
    Review Days
    130

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    Basic Information

    Device Name
    NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
    K Number
    K905702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dentsply Intl.
    Date Received
    December 20, 1990
    Decision Date
    April 29, 1991
    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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