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

    POLYVINYL SILICONE IMPRESSION MATERIAL

    K Number: K810825 · Decision Apr 14, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    POLYVINYL SILICONE IMPRESSION MATERIAL
    K Number
    K810825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dental-Material Gesellschaft
    Date Received
    March 24, 1981
    Decision Date
    April 14, 1981
    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 Dental-Material Gesellschaft

    K Number Device Name
    K810813 DMG-POLISHABLE COMPOSITE