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

    DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER

    K Number: K881245 · Decision Jul 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    120

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    Basic Information

    Device Name
    DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER
    K Number
    K881245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Cadco Dental Products, Inc.
    Date Received
    March 23, 1988
    Decision Date
    July 21, 1988
    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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