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510(k) Data Aggregation

    K Number
    K223706
    Device Name
    PMMA BLOCK
    Manufacturer
    Huliang(shanghai) Bio-Tech Co., Ltd.
    Date Cleared
    2023-05-12

    (151 days)

    Product Code
    EBG, EBI, MQC
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Huliang(shanghai) Bio-Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM. Indications for Use: - Temporary anterior and posterior crowns; - Temporary anterior and posterior bridges; - Removable structures for dentures; - Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
    Device Description
    PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
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