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

    Vista Rinse, Vista Rinse Plus

    K Number: K193409 · Decision Sep 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    275

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    Basic Information

    Device Name
    Vista Rinse, Vista Rinse Plus
    K Number
    K193409
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inter-Med/Vista Dental Products
    Date Received
    December 9, 2019
    Decision Date
    September 9, 2020
    Product Code
    KJJ
    Advisory Committee
    Unknown
    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
    KJJ Cleanser, Root Canal

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    Other Clearances by Inter-Med/Vista Dental Products

    K Number Device Name
    K193357 V-Mix
    K193447 Vista Dyes
    K193389 Vista Clear
    K190220 Vista FS, Vista FS Liquid
    K170101 Valiant Curing Light