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510(k) Data Aggregation
K Number
K243130Device Name
Integral Dental Unit
Manufacturer
GUANGDONG YADENG MEDICAL APPARATUS CO., LTD.,
Date Cleared
2025-06-27
(270 days)
Product Code
EIA, KLC
Regulation Number
872.6640Why 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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