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

    SILICONE ELASTOMER KIT

    K Number: K810869 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    SILICONE ELASTOMER KIT
    K Number
    K810869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Rapid Injection Systems Corp.
    Date Received
    March 31, 1981
    Decision Date
    April 29, 1981
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Rapid Injection Systems Corp.

    K Number Device Name
    K072479 FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD