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510(k) Data Aggregation
K Number
K071353Device 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
872.6250Why 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
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