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

    DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST

    K Number: K033045 · Decision Dec 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
    K Number
    K033045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3710
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Green Dent. Mfg, Inc.
    Date Received
    September 29, 2003
    Decision Date
    December 23, 2003
    Product Code
    EJH
    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
    EJH Alloy, Metal, Base

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    Other Clearances by American Green Dent. Mfg, Inc.

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    K033044 DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER