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510(k) Data Aggregation

    K Number
    K201683
    Device Name
    PMMA Block
    Manufacturer
    Huge Dental Material Co., Ltd.
    Date Cleared
    2020-11-03

    (134 days)

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

    Huge Dental Material Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMMA BLOCK particularly suitable for making 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; - Implant surgical guide; - 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. PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.
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    K Number
    K101029
    Device Name
    KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
    Manufacturer
    HUGE DENTAL MATERIAL CO., LTD.
    Date Cleared
    2010-08-16

    (125 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUGE DENTAL MATERIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for use as a tooth in a denture. These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
    Device Description
    The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent. Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
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