BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    PERIOFLEX TIP

    K Number: K923711 · Decision May 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    658

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    Basic Information

    Device Name
    PERIOFLEX TIP
    K Number
    K923711
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novadent, Ltd.
    Date Received
    July 27, 1992
    Decision Date
    May 16, 1994
    Product Code
    EFS
    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
    EFS Unit, Oral Irrigation

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