FDA for Handpiece:

510(K) Number: K181691,

Regulation Number: 872.4200,

Classification Product Code: EFB,

Subsequent Product Code: EGS

  • Wireless Control LED Ultrasonic Scaler
  • Features:

    Periodontics:(P1)

    Endodontics:(E1 )

    Scaling:(G1 G2 G4 )

    for EMS Woodpecker dental scaler handpiece

    Description

    1.multifunction Endo Perio scaling tips EMS Woodpecker scaler handpiece

    2. Compatible with EMS Woodpecker

    3.Perio / scaling / Endo treatment tip

    4. Brand new condition.

    5. 100% CE high quality.

    6. Best price from manufacturer.

    7.coated with special material.

    8. Widely used by worldwide dentists with positive feedbacks

    Specification:

    G1 Removal of supragingival deposits in all quadrants

    G2 Removal of heavy supragingival deposits on anterior teeth. Removal of orthodontic cements

    G4 The Universal gingival tip for removing Supragingival calculus and plaque

    E1 120°angle holder: Swishing anterior teeth coordinated with swished file after root canal preparation

    P1 The universal subgingival tip for periodontal pocket within 4mm and adjacent surface scaling.


  • 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:AC adapter: 100-240vac. 50-60Hz. 1 2AMax
    Output: 30Vdc. 1.3A
    For main unit: 30Vdc. 1.3A
    Wireless control fool pedal battery: 1.5VX2
    Receiving sensitivity: -114dB

    Primary vibration excursion of the tip:
    (a)Minimum, 1um, Deviation -50%
    (b)Maximum. 100um, Deviation +50%

    Output half-excursion:
    (a)Minimum, O.1N, Deviation -50%
    (b)Maximum. 2N, Deviation +50%

    Vibration frequency of the tip: 25-31KHz
    Input power: 30VA- 48VA
    Ultrasonic output power: 3W-20W
    Fuse: 125V 1.5A
    Water pressure: O1MPa-0.05MPa
    Weight of main unit: 0.75kg
    Weight of adapter: 0.25kg
    Size: 230mmx 155mm x 56mm
    5 Tips: G1, G2, G4, P1, E1

LCD Screen Cordless Hygiene Prophy Handpiece

Description:
Smart operation: Press the on/off key to start working effortlessly
Wide speed range: 500/1000/1500/2000/2500rpm/min, to meet various polishing needs
Two directions: Forward/Reverse
Single use prophy angles: Compatible with all universal disposable prophy angles, and refuse to reuse to ensure clean and safe
Mini head for small mouth: Improve the treatment experience for patients
Ergonomic design provides perfect balance
Operate comfortable and flexible
For teeth cleaning and polishing
Package:
Main unit 1pc
Disposable prophy angles 2pcs
Adapter 1pc
USB cable 1pc
Base 1pc
Payment
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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

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