FDA for Handpiece:

510(K) Number: K181691,

Regulation Number: 872.4200,

Classification Product Code: EFB,

Subsequent Product Code: EGS

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Description:
Brand: VRN
Model: VRN-A8 
As a new strategic product of VRN for the high-end ultrasonic scaler market, VRN-A8 absorbed the excellent quality as VRN ever did before, adopting the exclusive patent technology - wireless control, with multiple functions, automatic water supply, intelligent vibration technology. It brings you a convenient, faster and more comfortable experience for treatment.

The technical specification :
Automatic Frequency Tracking 
Patented Liquid Pumps, Digital Controlled 
Function: Scaling, Perio, Endo
Control: Wireless foot switch
Water Supply: Auto-water supply
Handpiece: LED detachable handpiece

Working conditions:
Temperature :5℃-40℃

Relative humidity ≤80%

Atmospheric pressure : 75KPa-106KPa
Power supply:

For AC adapter: 100-240Vac. 50-60Hz. 1.2AMax
Output: 30Vdc. 1.3A
For main unit: 30Vdc. 1.3A
Wireless control fool pedal battery: 1.5V×2
Receiving sensitivity: -114dB
Primary vibration excursion of the tip:
(a)Minimum, 1um, Deviation -50%
(b)Maximum. 100um, Deviation +50%

Output half-excursion:
(a)Minimum, 0.1N, Deviation -50%
(b)Maximum. 2N, Deviation +50%
Vibration frequency of the tip: 25-31KHz
Input power: 30VA- 48VA
Ultrasonic output power: 3W-20W
Period of use: 10 years
Fuse: 125V 1.5A
Water pressure: 0.01MPa-0.5MPa 
Weight of main unit: 0.75kg
Weight of adapter: 0.25kg
Size: 230mmx 155mm x 56mm
5 Tips: G1, G2, G4, P1, E1

Packing list:

1.   Main Unit             *1

2.   PH-1 Handpiece        *1

3.   Power Adaptor         *1

4.   Wireless Foot Switch  *1

5.   Water Bottle          *1

6.   G1/G2/G4/P1/E1 Tips   *1

7.   Foot Switch           *1

8.   Wrench                *1

9.   Endo Wrench           *1

10.  O Ring               *2

11.  Instruction Manual   *1

12.  Endo Files           *2

13.  QC Certificate       *1

14.  Waterproof Paste     *1

15.  Cap O Ring           *1

16.  Bottle Cap Gasket    *1

17.  Syringe              *1

18.  Adapter              *1

 

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 DA-20

Function & Introduction:
This Scaler adopts piezoceramic ultrasonic technology, which uses high-frequency and high-energy vibrations generated by ultrasonic waves to clean the surface of the teeth, break up calculus and stains in the periodontal pockets by tips, and then the rubble and plaque are washed down by the water spray produced by the device. It is designed for gingival, subgingival cleaning and root canal washing and has the function of automatic water supply.
It has following characteristics:
. The irrigation system inside the product is made of anti-bacterial materials. The liquids used in clinics, such as hydrogen peroxide, chlorhexidine, sodium hypochlorite, etc., can be applied in the mode of automatic water supply system, which can significantly improve the performance of teeth cleaning and root canal washing.
. The handpiece can be sterilized at 135℃ temperature and 0.22 MPa pressure.
. Automatically search for the best working condition, the performance of device is more stable.
. The device has a built-in computer microprocessing chip, which can intelligently control the working power and make treatment more comfortable.
. The wireless foot switch is used to remotely control the unit, which is more convenient to operate. At the same time, wired foot switches can also be selected according to user needs.
. High-brightness LED, which can improve the efficiency of clinical operation, and it can also use ordinary plug-in handpiece that has high compatibility.
. The product service life is 10 years.
Specifications:
. Input Voltage：220 V±22 V～ ，50/60 Hz
. Input Power：35 VA
. Batteries of wireless foot switch：AA Batteries×2
. Receiving sensitivity: -114 dB, receive frequency：2.4 G-2.5 G
. Tip amplitude： minimum,1 μm, deviation -50%
maximum, 100 μm, deviation +50%
. Half deflection force：minimum, 0.1 N, deviation -50% maximum, 5 N ，deviation +50%
. Vibration frequency of tip：18 kHz～45 kHz
(Note：The vibration frequencies of different types tips are different, but they are all distributed within the described range.)
. Output Voltage of tip：3 W～20 W
. Fuse：T1AH250V
. Weight：1.8 kg
. Operation modes：continuous running
. Protection against electric shock rating：Class Ⅱ equipment
. Protection against electric shock degree：B-type application part
. Ingress protection rating ： Ordinary equipment (IPX0), Wired foot switch is waterproof equipment （IPX1）, Wireless foot switch is waterproof equipment（ IPX4）
. Degree of safety application in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide:Non-AP,APG type equipment
. Wireless foot switch:
Emission frequency: 2.412 GHz-2.462 GHz
Modulation type: GFSK
Effective radiated power：12 dbm
Packing List:

#

ITEM

QTY

REMARK

1

Main Unit

1

 

2

PH-1 LED Scaler Handpiece

1

 

3

Power Supply Cord

1

 

4

Wireless Foot Control

1

 

5

Water Bottle

1

 

6

Perio Tips

1

E14

7

Perio Tips

2

P1

8

Perio Tips

1

G2

9

Perio Tips

2

G1

10

Implant Tips

2

G4

11

Scaler Tips

1

E1

12

Scaler Tips

1

P4

13

Endo File

2

25#

14

O Ring

2

 

15

Torque Tip Wrench

1

 

16

Endo File Wrench

1

 

17

Waterproof Sticker

1

 

18

O Ring

2

4*1

19

O Ring

2

3.2*1

20

Screwdiriver

1

 

21

Instruction manual

1

 

22

Packing List

1

 

23

QC Certificate

1

 

24

Foot Control With Wire

1

 

25

Tips Contrast Cord

1

 

26

Fuse

1

 

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Description：

Power：100-240V    50/60Hz

With 3-speed settings: 500、1500、2500rpm/min

Torque range：＞1.5N.cm

Compatible with all universal disposable prophy angles

Ergonomic design provides perfect balance

Operate comfortable and flexible

For teeth cleaning and polishing

 

Package：

Main unit   1pc

Disposable materials  2pcs

Adapter   1pc

USB cable  1pc

Base   1pc

 

Notes:Delivery belt 2 disposable prophy angles

 

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Description：

Gear ratio：4:1 reduction

Motor Weight：2.39 oz （68g）

Speed：4000 rpm

Noise：≤60dB

135 autoclavable

4 Holes

Features:

1.This prophy air motor is intended to be used with disposable prophy angle and prophy paste by a trained dental professional to perform dental prophylaxis

2.Smooth, vibration-free

3.Ergonomic design provides perfect balance, 360 degree swivel

4.Compatible with all most standard disposable prophy angles

 

Package：

Nose cone*1

Air motor*1


 Payment
1.We only accept payment by Paypal.                                                   
2.Please make sure you PayPal account is valid prior bidding.

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About US
We're one of the largest online dental suppliers based on our own qualified manufacturers in China.
We supply all dental items with very nice qualities and the best reasonable prices for worldwide dentistry students, dentists and other professionals.
Looking forward to our friendly & win-win cooperation.
Our working time: Monday - Friday   9:00 AM - 5:30PM (Beijing)

Company name: Dreamland Technology Ltd
City, State: Beijing, China
Telephone number: 0371-56645662
The following FDA Disclaimer is required.

REFERENCE:
Statement：The sale of this item may be subject to regulation by the U.S. Food & Drug Administration and state and local regulatory agencies.You can bid on this item if you are an authorized purchaser. If the item is subject to FDA regulation, We will verify your status as an authorized purchaser of this item before shipping of the item.If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health.(This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort.)
This item has been cleaned and treated according to the manufacturer's instructions.
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

Il 11-apr-2024 alle 12:03:32 CEST, il venditore ha aggiunto le seguenti informazioni sulloggetto:

DataCaciques