BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER

    K Number: K033044 · Decision Dec 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    449

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    Basic Information

    Device Name
    DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
    K Number
    K033044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Green Dent. Mfg, Inc.
    Date Received
    September 29, 2003
    Decision Date
    December 21, 2004
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by American Green Dent. Mfg, Inc.

    K Number Device Name
    K033045 DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST