Product Basic Information
Product Name：Dental X-ray System
Working principle：The high voltage generator provides high voltage to both ends of the X-ray
tube filament and metal target in the internal X-ray source assembly, a large number of electrons are
generated on the cathode filament of the X-ray tube and move at a high speed in the vacuum tube,
impact the metal target to generate the X-ray. The X-ray penetrate the different tissue densities of the body, such as teeth and muscles after pass through the X-ray window and beam tube, the X-ray which
carry image information through body tissue, are passed through image receiving devices such as
phosphor sheets, film or digital image receivers, to show different densities of human tissue images.
tube filament and metal target in the internal X-ray source assembly, a large number of electrons are
generated on the cathode filament of the X-ray tube and move at a high speed in the vacuum tube,
impact the metal target to generate the X-ray. The X-ray penetrate the different tissue densities of the body, such as teeth and muscles after pass through the X-ray window and beam tube, the X-ray which
carry image information through body tissue, are passed through image receiving devices such as
phosphor sheets, film or digital image receivers, to show different densities of human tissue images.
Application Range: used for the teeth to taking an X-ray photography, with an intraoral image
receiver, images are obtained for the clinical diagnosis.
Structural composition: the product consists of the host (including the X-ray tube, controller and
rechargeable battery), beam limiting tube, power adapter, stand and exposure switch.
Product DescriptionProduct Description
1.Power Adapter Input Voltage Uniphase AC 100 ～240V，±10% Supply Frequency 50/60Hz，±1Hz Input Power 286W
2.Output Power 25.2W
3.Charge voltage DC 25.2V
4.Charge current 1.0A
5.Nominal value of the focal point 0.8mm
6.Anode angle 19º
7.Available maximum tube voltage at 2mA 60kV
8.Maximum output electric power 0.12kW
9.Maximum loading factor combination 60kV 、2mA 、2s
10.Repeatability of radiation output No more than 0.5
11.Tube voltage (The deviation is within the range of ±10%) 60kV
12.Tube current (The deviation is within the range of ±20%) 2mA
13.Running mode Discontinuous operation, maximumexcitation (open) time : minimumexcitation (close) time = 1：30
14.Total filtration of X-ray tube assembly >2.5mm Al
15.Intrinsic filtration of X-ray tube assembly 0.75mm Al
16.Additional filtration 1.00mm Al
17.Half-value layer ≥1.5mm Al（60kV）
18.Leakage radiation ≤0.25mGy/h（60kV 、2mA 、2s）
19.Adjustment range of the loading time 0.01 ～2.00s，adjustable
20.Distance of the Focal point to skin (The deviation is within 0~5%)
211mm±3mm21.X-ray field size at the end of beam limiting tube round ，Φ 56mm±3mm22.Nominal electric power 0.12kW（60kV 、2mA 、0.1s）23.Available maximum tube current at 60kV 2mA
24.Inverter frequency of the high voltage generator 70kHzNote: the loading time adjustment range meets the R10 series for the adjustment.
Product basic safety features
(1) Safety category：Class Ⅱ or internal power supply class ，does not work while charging.
(2) Classified by electric shock protection type：Type B application section.
(3) Classified by the degree of protection against fluid intake：Common equipment.
(4) Classified by the manufacturer's recommended disinfection and sterilization methods：As required by the manufacturer to carry out.
(5) Classified by the degree of safety for use with flammable anesthetic gases mixed with air or with oxygen or nitrous oxide：NonAP/APG type.
(6) Classified by operation mode：Discontinuous operation，Maximum excitation (open) time： Minimum excitation (close) time =1：30.
(7) The product has no application part with protection against defibrillation discharge effect.
(8) Whether the equipment has a signal output or input part：No.
(9) The product is a common equipment.
(10) Permanent or non-permanent installation equipment：Non-permanent installation equipment.
(11) Radiation type：Ionizing radiation.
(12) Radiation property：X ray.
(13) Radiation distribution：The X-ray radiates from the positive direction of 6cm circle in the window of the limited beam barrel when used.
(1) Safety category：Class Ⅱ or internal power supply class ，does not work while charging.
(2) Classified by electric shock protection type：Type B application section.
(3) Classified by the degree of protection against fluid intake：Common equipment.
(4) Classified by the manufacturer's recommended disinfection and sterilization methods：As required by the manufacturer to carry out.
(5) Classified by the degree of safety for use with flammable anesthetic gases mixed with air or with oxygen or nitrous oxide：NonAP/APG type.
(6) Classified by operation mode：Discontinuous operation，Maximum excitation (open) time： Minimum excitation (close) time =1：30.
(7) The product has no application part with protection against defibrillation discharge effect.
(8) Whether the equipment has a signal output or input part：No.
(9) The product is a common equipment.
(10) Permanent or non-permanent installation equipment：Non-permanent installation equipment.
(11) Radiation type：Ionizing radiation.
(12) Radiation property：X ray.
(13) Radiation distribution：The X-ray radiates from the positive direction of 6cm circle in the window of the limited beam barrel when used.
X-ray tube technical specification
1.The X-ray tube model XD10D-0.5 / 70
2.Nominal value of the focal point 0.8mm
3.Target material Tungsten
4.Maximum working tube voltage 70kV
5.Anode angle of the X-ray tube 19º
6.Intrinsic filtration 0.75 mm Al
7.Filament current 2.0 A
8.Filament voltage 2.85 ± 0.5 V
❖FDA Statement
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, you can bid on this item only if you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
Company name: Dreamland Technology Ltd
City, State: Beijing, China
Telephone number: 0371-56645662
FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ
FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS
FDA for Scaler: 510(K) Number: K163414, Regulation Number: 872.4850, Product Code: ELC