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510(k) Data Aggregation

    K Number
    K140836
    Device Name
    ZIBONE ZIRCONIA BLOCKS
    Manufacturer
    COHO TECHNOLOGY CO., LTD
    Date Cleared
    2015-06-17

    (441 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    COHO TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.
    Device Description
    "Zibone Zirconia Blocks" are made from partially sintered zirconium oxide. The devices are to be CNC machined to construct dental restorations and substructures such as crowns and bridges with the aid of CAD/CAM technology. The devices are in cylinder forms with a constant diameter of 98mm and variety of heights from 12 to 20 mm, and in rectangular bar forms with various lengths and widths with the height of 16mm.
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    K Number
    K132585
    Device Name
    ZIBONE CERAMIC DENTAL IMPLANT SYSTEM
    Manufacturer
    COHO TECHNOLOGY CO., LTD
    Date Cleared
    2014-06-04

    (292 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    COHO TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved.
    Device Description
    Zibone ® Ceramic (Zirconia) Dental Implants are threaded; root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices. The implants are manufactured from yttrium stabilized zirconium oxide bioceramics material conforming to ISO 13356-2008: Implants for surgery-ceramic materials based on yttria-stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment), which simplifies the surgical procedures. The implants are single use devices and are delivered in sterile condition have been sterilized with moisture heat. Zibone ceramic dental implants are also subjected to a sandblasting process that is used to impart the surface of the devices to enhance the osseointegration process. Zibone dental implants are offered in three diameters (3.6mm, 4mm and 5mm) and 5 insertion lengths (8mm, 10mm, 11.5mm, 13mm and 14.5mm) for different teeth. The general rule is to select largest and longest implant size that the indication permits.
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