Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071353
    Device Name
    FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
    Manufacturer
    SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2007-12-14

    (213 days)

    Product Code
    KLC
    Regulation Number
    872.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.
    Device Description
    The Foshion Chair Mounted Dental Unit is a dental operative unit attached to a dental chair. There are three main parts to the product: a dental chair, a dental unit, and a stool for the dentist. The dental chair has adjustable headrest, backrest, seat with extension for leg support, and armrests. The dental unit consists of a floor box to which are attached a number of operative units: light, x-ray viewer, cuspidor, cup filling device, control panel, instrument tray, and foot control. The instrument panel also includes a 3-way syringe, saliva ejector, air suction, and handpiece attachments
    Ask a Question

    Page 1 of 1