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510(k) Data Aggregation

    K Number
    K151764
    Device Name
    YAMAHACHI PMMA DISKS
    Date Cleared
    2015-11-23

    (146 days)

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

    YAMAHACHI DENTAL PRODUCTS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.
    Device Description
    Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate temporary crowns and bridges. After polishing, the prosthesis is adjusted in the patient's mouth and cemented or bonded in place, where it remains until removal when the permanent restoration is available. The restoration process begins in the dental office with an intraoral scan of the affected tooth and the surrounding teeth. Proprietary software takes this digital image and creates a replacement part for the missing areas of the tooth, creating a virtual restoration. The software sends this virtual data to a milling machine where the replacement part is carved out of a Yamahachi PMMA Disk. The optical impression system, software, and milling machine are not part of the device. The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments. Yamahachi PMMA Disks are available in different shapes and shades, with disks of all shades available in different dimensions (diameter, thickness and profile margin). It is intended for use in both open and closed CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn, block, pin and 2-pin.
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