BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    TUBULITEC PRIMER

    K Number: K851052 · Decision Jul 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    2
    Review Days
    139

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    Basic Information

    Device Name
    TUBULITEC PRIMER
    K Number
    K851052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dental Therapeutics AB
    Date Received
    March 14, 1985
    Decision Date
    July 31, 1985
    Product Code
    LBH
    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
    LBH Varnish, Cavity

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    Other Clearances by Dental Therapeutics AB

    K Number Device Name
    K851053 TUBULITEC LINER