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510(k) Data Aggregation

    K Number
    K243130
    Device Name
    Integral Dental Unit
    Manufacturer
    GUANGDONG YADENG MEDICAL APPARATUS CO., LTD.,
    Date Cleared
    2025-06-27

    (270 days)

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

    GUANGDONG YADENG MEDICAL APPARATUS CO., LTD.,

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