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

    TUBULITEC LINER

    K Number: K851053 · Decision Jul 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    TUBULITEC LINER
    K Number
    K851053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dental Therapeutics AB
    Date Received
    March 14, 1985
    Decision Date
    July 25, 1985
    Product Code
    EJK
    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
    EJK Liner, Cavity, Calcium Hydroxide

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    Other Clearances by Dental Therapeutics AB

    K Number Device Name
    K851052 TUBULITEC PRIMER