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

    BIOCALEX 6/9

    K Number: K941532 · Decision Aug 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    BIOCALEX 6/9
    K Number
    K941532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Probe, Inc.
    Date Received
    March 30, 1994
    Decision Date
    August 2, 1994
    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 Bio-Probe, Inc.

    K Number Device Name
    K922985 CLEAN UP