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

    ORAL-B DENTAL FLOSS WITH FLUORIDE

    K Number: K925409 · Decision Jan 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    8
    Review Days
    94

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    Basic Information

    Device Name
    ORAL-B DENTAL FLOSS WITH FLUORIDE
    K Number
    K925409
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oral-B Laboratories
    Date Received
    October 26, 1992
    Decision Date
    January 28, 1993
    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 Oral-B Laboratories

    K Number Device Name
    K942633 ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
    K943157 ORAL-B ULTRAFLOSS WITH FLLUORIDE
    K943182 ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
    K932990 ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
    K925408 ORAL-B DENTAL TAPE WITH FLUORIDE
    K913603 FIBRETWINS
    K883024 ORAL-B FLOSSERS