BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UTILITY WAX STRIPS, SPEARMINT

    K Number: K880607 · Decision Mar 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    201
    Registration Numbers
    201
    Same Product Code
    24
    Applicant Total
    11
    Review Days
    48

    Basic Information

    Device Name
    UTILITY WAX STRIPS, SPEARMINT
    K Number
    K880607
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6890
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    COLUMBUS DENTAL MFG. CO.
    Date Received
    February 12, 1988
    Decision Date
    March 31, 1988
    Product Code
    EGD
    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
    EGD Wax, Dental, Intraoral

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    Other Clearances by COLUMBUS DENTAL MFG. CO.

    K Number Device Name
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    K871164 GLUMA(TM) BONDING SYSTEM
    K871165 LUMIFOR(TM) COMPOSITE
    K863816 IVORY PREMIUM RUBBER DAM
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    Search all 11 clearances from COLUMBUS DENTAL MFG. CO. →