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510(k) Data Aggregation

    K Number
    K233921
    Device Name
    Luvis Chair (LC700C)
    Manufacturer
    DENTIS CO., LTD.
    Date Cleared
    2024-09-06

    (268 days)

    Product Code
    KLC, EIA
    Regulation Number
    872.6250
    Why did this record match?
    Product Code :

    KLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
    Device Description
    The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support. Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.
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    K Number
    K151987
    Device Name
    DCI Edge Dental Chair with Operative Unit
    Manufacturer
    DCI
    Date Cleared
    2016-06-01

    (320 days)

    Product Code
    KLC, EIA
    Regulation Number
    872.6250
    Why did this record match?
    Product Code :

    KLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
    Device Description
    The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.
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    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?
    Product Code :

    KLC

    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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    K Number
    K971063
    Device Name
    OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
    Manufacturer
    KING DENTAL CORP.
    Date Cleared
    1997-06-03

    (71 days)

    Product Code
    KLC
    Regulation Number
    872.6250
    Why did this record match?
    Product Code :

    KLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.
    Device Description
    Not Found
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    K Number
    K963209
    Device Name
    PROSTYLE COMPACT
    Manufacturer
    PLANMECA OY
    Date Cleared
    1996-10-24

    (69 days)

    Product Code
    KLC
    Regulation Number
    872.6250
    Why did this record match?
    Product Code :

    KLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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