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510(k) Data Aggregation

    K Number
    K163482
    Device Name
    Orthodontic Acrylic 2
    Manufacturer
    Lang Dental Manufacturing Co., Inc.
    Date Cleared
    2017-05-31

    (170 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lang Dental Manufacturing Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)
    Device Description
    Orthodontic Acrylic 2 is a fast curing self-cure 2 part system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.
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