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

    IMPRESSION MATERIAL, TRIFLEX SILICONE

    K Number: K760240 · Decision Jul 26, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    3
    Review Days
    11

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    Basic Information

    Device Name
    IMPRESSION MATERIAL, TRIFLEX SILICONE
    K Number
    K760240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oratec Dental Products
    Date Received
    July 15, 1976
    Decision Date
    July 26, 1976
    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 Oratec Dental Products

    K Number Device Name
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