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

    DENTAL FLOSS HOLDER

    K Number: K831254 · Decision May 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    DENTAL FLOSS HOLDER
    K Number
    K831254
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Sewon Industry
    Date Received
    April 18, 1983
    Decision Date
    May 9, 1983
    Product Code
    JES
    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
    JES Floss, Dental

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    Other Clearances by Sewon Industry

    K Number Device Name
    K870996 SEWON DENTAL FLOSSER
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    K813248 DENTAL FLOSS HOLDER
    K811926 SE WON(ALUMINUM) DENTAL FLOSS HOLDER
    K811555 DENTAL FLOSS HOLDER