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510(k) Data Aggregation

    K Number
    K233859
    Device Name
    BASIS FLOW II
    Date Cleared
    2024-03-05

    (90 days)

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

    Yamahachi Dental MFG., Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BASIS FLOW II is intended for fabrication or repair of the denture base.
    Device Description
    BASIS FLOW II is supplied as components in powder and liguid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator. To fabricate the denture base, the powder and liguid materials are mixed and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).
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    K Number
    K172683
    Device Name
    Yamahachi Pink CAD/CAM Disk
    Date Cleared
    2018-01-16

    (132 days)

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

    Yamahachi Dental Mfg., Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    YAMAHACHI Pink CAD/CAM Disk is used for the fabrication of dentures.
    Device Description
    Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate dentures. 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 included in this submission. The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments. Yamahachi Pink 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, closed and block type CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn and block type can be used for any milling machine with the appropriate and compatible CAM system.
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