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510(k) Data Aggregation

    K Number
    K103550
    Device Name
    YOBOSHI DENTAL UNIT
    Date Cleared
    2011-01-04

    (32 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair
    Device Description
    Yoboshi dental units with chairs are driven by imported low-voltage DC motor with imported air spring auxiliary balance to keep a safe and stable operation of equipment and low noise. With two pieces of NSK high speed H.P and one piece of NSK lowspeed H.P, it is easy and credible for working. The single-form seamless leather cushion provides comfort for the patient to sit and for the doctor to clean and disinfect more easily. It is applicable for the dental clinic. The unit is composed of integral ceramic spittoon, air-controlled balanced instrument-arm, newlydesigned cold light. The models include A8000, A8000-I, A8000-II. All of these types follow the same design principle and intended use, and comply with ISO7494-1:2004, ISO7494-2:2003. The hose connectors of these types comply with ISO9168:1991. The air-motors of these types comply with ISO13294: 1997. Dental patient chair complies with ISO 6875:1995. All of these types of applicant devices consist of similar components with similar function and different appearance, these components include: - Electric pedal switch ● - Control key for mouth lamp - Wash cuspidor - Gargle water control - Pedal switch - Handrail - Backrest - Headrest - Cuspidor - Rising pipe - Lamp arm - Operation light - Seat cushion for child
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