FDA USA SKYSEA Dental Ultrasonic Electric Piezo Scaler Handpeice Fit EMS Tips

Description

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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.
Portable Dental Ultrasonic Piezo Scaler Handpiece Tips Bottles f/ EMS
Description
Ship from China to Other Countries!
Ship from USA to USA, the Upgraded scaler with
FDA CERTIFICAION
！！！
Packing List
1.Main unit
2.Detachable handpiece
3.Adapter of power supply
4.Foot switch
5.Scaling tip G1 G2 G3 G4 P1
6.Scaling tip Torque wrench
7.Handpiece decorative ring
8.Waterproof ’0” ring
9.Packing list
10.Instruction manual
11.Warranty card
12.Reservoir(350ml)
13.Reservoir(450ml)
Screw connection or coupling of its Handpiece, tube, and scaler tips is compatible with other Brands like EMS, etc.
Instruction
The new product SKE1 ultrasonic scaler has scaling, perio, endo and auto water supply functions with the following
features:
1.With auto water supply function,easier operation.
2.The inner water pipe is made from antiseptic material, clinical fluids, such as Hydrogen peroxide,chlorhexidine and sodium Hypochloritc,etc, can be used perfectly under the mode of auto-water supply system so that the performance of perio and endo is improved dramatically.
3.The handpiece is detachable and can be autoclaved to the temperature of 135℃ and the pressure of 0.22MPa.
4.Automatic frequency tracking ensures that the machine always works on the best frequency and performs more steadily.
5.Controlled by PC, easy operation and more efficient for scaling. These features make SK-E1 become a new generation product in the world dental market.
Pay attention to its Three Highlight Features!
No.1 It uses voltage transformer rather than AC adapter to avoid the feeling of pain when scaling!
No.2 The main unit uses fireproof material.
No.3 The auto-water supply system adapts diaphragm pump, which will be more durable than peristaltic pump.
The main technical specifications
1.Voltage Transformer (please leave a message about which type you need, 110v or 220v)
2.Main unit input:24V~    1.3A
3.Output primary tip vibration excursion:≤100m
4.Output half-excursion force:<2N
5.Output tip vibration frequency:28kHz±35Hz
6.Output power:3W to 20W
7.Main unit fuse:T1.6AL 250V
8.Adapter fuse:T0.5AL 250V
9.Weight of main unit:1.17g
10.Weight of adapter:1.2kg
11.Operating mode:Continuous operation
12.Type of protection against electric shock:Class II equipment
13.Degree of protection against electric shock:Type BF applied part
14.Degree of protection against harmful ingress of water:Ordinary equipment
15.Protection degree against water(used on the foot switch):IPX1
16.Applied part of the equipment:handpiece and tip
17.Degree of safety of application in the presence of a Flammable Anaesthetic Mixture with air or with Oxygen or Nitrous Oxide:
Equipment not suitable for being used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
Standard shipping to
United Sates, Macao, Hong Kong, Taiwan, North Korea, South Korea, Japan,  Philippines, Cambodia, Malaysia, Mongolia, Thailand, Singapore,  Indonesia, Vietnam, Australia, Papua New Guinea, New Zealand, Ireland,  Austria, Belgium, Denmark, Germany, France, Finland, Canada, Luxembourg, Malta, Norway, Portugal, Sweden, Switzerland, Spain, Greece, Italy,  United Kingdom
by EMS or Yanwen Express delivery from China 5-10 working days.
Other countries, please contact us to check the extra shipping cost. Thank you!
Feedback
IMPORTANT INFORMATION ON OUR POLICY AND FEEDBACK
Please leave me
FIVE STAR POSITIVE
feedback if you are satisfied with our items.
We try to be fair and accurate with all of our product listings and descriptions. Please read each auction, bid, and sale carefully.
We will appreciate it if you please email us before leaving negative feedback. If there is a problem, we can work together to resolve it.
We strive to always be extremely fair and always try to work with reasonable customers.
Negative feedback doesn't go away and should only be left as a last resort! We strive for positive feedback, harmonious relations and even friendships.
We will always make every attempt possible to resolve issues if we made a mistake.(It happens). Please do not assume a mistake is intentional.
Let us know if our service could be better!!
Shipping
International Shipping to worldwide.
Handling within 24 business hours.
Tracking info of your parcel is available.
Returns could be accepted within 60 days after receipt of the item.
Import duties, taxes and charges are not included in the item price or shipping charges. These charges are the buyer's responsibility.Please check with your country's customs office to determine what these additional costs will be prior to bidding/buying.
It usually takes 15-45 business days to arrive by economy international shipping and 7-12 business days by express. The following form is for your reference.
Payment
We accept PayPal payment ONLY, it is easy and safe. Payment should be sent within 7 (SEVEN) days of auction closing. All winning bidders whom won our item, please let me know your contact number after you made the full payment , we need this number to make sure you can receive your item in time, and also for emergency contact consideration.
Returns
Returns could be accepted within 30 days after receipt of the item.
Terms of Sale:
Refund or replacement request is available only the requests within 1 week after parcel received & returning the item as the same condition as received. Please contact us to request a return authorization. Your name, auction number, and reason for return should be included in the email. All items returned must contain all original packaging materials.Please repack the item carefully. Items returned will be tested and a new replacement will be shipped to the buyer immediately when found defective. In the event that a suitable replacement is not available then a refund will be issued. Shipping, handling and insurance fees are non refundable. If the item is found non-defective, the item will be sent back to the buyer at buyer's expense. Items returned without RMA number will be refused and returned to the sender. Buyer is responsible for All Return Postage and Shipping Charges. Buyer is responsible for additional shipping costs for items that are returned refused and / or undeliverable. We do not accept any returns without an authorization number on the box or label it is being returned.
Contact us
We will reply all messages within 24 business hours and we are able to give you a quick response during the duty time. If we are off duty, please kindly be patient and give us a little more time, not just leave the neutral or negative feedback without communication. Every problem will be solved ASAP if you contact us!
Our working time
Monday To Friday:
9:00 am --- 12:00am
1:30pm ---6:00pm
(Please Refer to Beijing Time.)
Copyright©Dreamland Dental Store,All rights reserved
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
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