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

    PERIO-MED DENTAL FLOSS

    K Number: K944034 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    2
    Review Days
    357

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    Basic Information

    Device Name
    PERIO-MED DENTAL FLOSS
    K Number
    K944034
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Whitehill Oral Technologies, Inc.
    Date Received
    August 2, 1994
    Decision Date
    July 25, 1995
    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 Whitehill Oral Technologies, Inc.

    K Number Device Name
    K963746 IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID