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The Integral Dental Unit 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.

The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures. Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions. The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest. The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168. Basic parameters/use conditions/power supply specifications is as follows: ◆Noise ＜70 dBA ◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding. Power input: 380 VA Water filter hole diameter: <90µm Air filter hole diameter: <25µm ◆Saliva ejector Weak saliva: - vacuum degree >15 kPa; - water pumping rate＞80 mL/min Strong saliva: - vacuum degree >25 kPa; - water pumping rate＞1000 mL/min ◆Instrument tray Rotating angle: >270º Up-down moving range: >440mm Max. Load: <5 Kg ◆Film viewer Power supply: 24 V ac Inside power supply Power input: 80 VA ◆Operating light Power supply: 12 V ac Inside power supply Power input: 50 VA Illuminance: 5 000~20 000 Lx Radiant heat: <200 W/m² @ max. illuminance Color rendering index: >85 Ra ◆Foot switch Tripping force: >10N and <30N Degree of protection against harmful ingress of water: IPX4(foot switch) Service life: >25 000 repeats ◆Dental chair Power supply: 24 V dc Inside power supply Loading capacity: 1323N (about 135 Kg) Loading capacity of headrest: 300N (about 30Kg) Moving range of headrest: 120mm Range of backrest when going backwards: 90º~170º Seat cushion's maximum height away from ground: 730mm Seat cushion's minimum height away from ground: 450mm Attachment ----- Amalgam separation device It has a medical device product registration card Attachment parameters are reflected in its operating instructions ◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm ◆Environment for operation Temperature: +5°C to +40°C Relative humidity: 30% - 80% Atmospheric pressure: 86kPa ~ 106kPa

The Dental Unit 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.

The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.

The dental delivery system is a device intended to support the instruments used by the dental practitioner, delivering those instruments to an accessible position during a dental procedure. This device may control and be the means of delivering compressed air, water, vacuum and low voltage electricity to a variety of instruments commonly used in dental practice.

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The BDC Dental Unit 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.

The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.

The Firstar Dental Unit is intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Firstar Dental Unit is intended for use by dental practitioners in a clinical environment.

The Firstar Dental Unit (also known as the delivery unit or delivery system) is a combination of dental equipment components used to carry, position, and control the devices used in the practice of dentistry. Delivery systems provide for hand pieces and other various accessories by delivering air, water, vacuum and low voltage electricity to the dentist during procedures. Depending on the configuration, it includes combinations of a Doctor Control Head (delivery head), Delivery System Foot Switch (sometimes referred to as a rheostat), Cuspidor, Side Box (Control Box), High Volume Evacuator (HVE), Saliva Ejector (SE), and an Air and Water Multifunction Syringe. Air, water, vacuum, drainage, and electrical power utilities are delivered through the shut-off valves, pressure regulators, and electrical transformers located in the post mounted utility box. Subsequently, internal tubing delivers the air, water and vacuum to the control head and to the dental hand pieces and multifunction syringe. Low voltage electricity is delivered to the control head for operating items such as scalers, electric hand pieces and fiber optic light sources. The Firstar Dental Unit is available in various configurations and mounting styles including dental chair mounted, mobile cart mounted, and wall mounted on a dental chair, the Firstar Dental Unit can be configured in two distinct styles - a pivot mounted unit which allows for ambidextrous access to the patient, and a post mounted unit which includes a side box located on one side of the dental chair that can mount a cuspitor (spittoon) on it. Despite the various applications, the key elements of the Dental Unit such as the internal plumbing, tubing, materials, power sources, utility connections, delivery head internal components, and overall operating principles remain the same. The control head allows operators to place surgical equipment on top of the tray and it provides controls for hand piece water pressure, air pressure and electrical power. Additionally, controls for a Firstar Dental Chair are often integrated on the control head if the dental unit is configured to mount on a dental chair. If equipped, the cuspidor bowl allows 90 decrees ande rotation that provides access to collect the patient's saliva during dental treatment. The side box provides controls for the cuspidor cup fill, bowl rinse, air, and pressure regulators for the air and water quick disconnect outlets. Various ancillary devices can be connected to the Firstar Dental Unit by means of standard ISO 9168-20 connections including but not limited to: pneumatic handpieces, electric micromotors and handpieces, air/water syringes, piezo or magnetostrictive dental scalers, curing lights, intraoral cameras, saliva ejectors, and high volume evacuators. 24VAC power supplied from the Junction Box Power Supply can be used to power electrically operated ancillary equipment such as electrical handpieces, dental does not manufacture the aforementioned devices except for the air/water syringes, saliva ejectors, and high volume evacuators.

K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.

N2 is intended to supply power to and serve as a base for dental devices and accessories. This 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.

The N2 is a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry. The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions. The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

The Dental Unit 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.

The Dental Unit(model: Mare) is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry. Dental Unit (model: Mare) consists of dental chair, arm dentist unit, assistant's unit, dental light, cuspidor, water unit, and multi-function foot control. It mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Dental Unit (model: Mare) which are attached by means of industry standard ISO connections. The ancillary dental devices include pneumatic handpieces, 3-way syringe, strong suction and weak suction vacuum instruments. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are 510k clarence in the K142206. Based on Safety does not manufacture pneumatic handpieces, the pneumatic handpieces shall be purchased by the enduser. The recommended pneumatic handpieces are 510(k) clearance K170229 and K170236, which are held by GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. None of the Dental Unit (model: Mare), parts or accessories are provided sterile.

ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.

This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.