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

    HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

    K Number: K992609 · Decision Sep 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
    K Number
    K992609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kay See Dental Mfg. Co.
    Date Received
    August 4, 1999
    Decision Date
    September 22, 1999
    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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