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510(k) Data Aggregation

    K Number
    K033045
    Device Name
    DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
    Manufacturer
    AMERICAN GREEN DENT. MFG, INC.
    Date Cleared
    2003-12-23

    (85 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

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

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

    "DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.

    "DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

    "DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.

    "DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

    Device Description

    General:- Dental Alloys
    Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Dream Bond, DreamCast V, DreamCast Chrome, Dream FlexiCast, and Dream LitheCast devices.

    The document is a 510(k) premarket notification letter from the FDA to American Green Dental Manufacturing, Inc. It states that the referenced devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the new devices are as safe and effective as existing ones, but it does not detail specific acceptance criteria or performance studies of the devices themselves within this document.

    The document focuses on:

    • FDA's determination of substantial equivalence (K033045).
    • Regulation numbers and product codes for the devices.
    • General controls and additional controls that may apply.
    • Contact information for various FDA offices.
    • Indications for Use for each device.
    • Classification as Prescription Use.

    Therefore, I cannot provide the requested information based on the text provided.

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