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

    SILICONE IMPRESSION MATEOIAL

    K Number: K771248 · Decision Jul 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    2
    Review Days
    4

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    Basic Information

    Device Name
    SILICONE IMPRESSION MATEOIAL
    K Number
    K771248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Interstate Dental Co., Inc.
    Date Received
    July 11, 1977
    Decision Date
    July 15, 1977
    Product Code
    ELW
    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
    ELW Material, Impression

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    Other Clearances by Interstate Dental Co., Inc.

    K Number Device Name
    K771257 ACRY TEMP