FDA Dental Ultrasonic Scaler + tips+2 Bottles Fit Cavitron EMS / Handpiece CN#1

Description

Description:
Ultrasonic Piezo Scaler SK-E1 :
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 SK-E1 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.
Scaler Handpiece:
Features:
1. SANDENT/
SKYSEA
® Detachable Scaling Handpiece.
2. Brand New; Durable; 100% High Quality.
3.
Compatible with EMS, SKYSEA/DTE SATELEC Ultrasonic Dental Scaler Cable & Tips.
4.
Autoclavable under the high temperature of 135℃ and pressure of 0.22Mpa
5. Widely used by worldwide dentists with
high praise.
5PCS Scaler Tips:
G1: Remove calculus and bacterial plasue on supragingival,
neck of teeth and hard calculus on the teeth point.
G2: Remove supragingival heavy calculus.
G3: Remove the calculus and bacterial plasue on subgingival interdental calculus.
G4: Remove all supragingival calculus and bacterial plasue.
G5: Remove supragingival and neck calculus and bacterial plasue.
G6: Remove supragingival heavy calculus.
P1: Remove subgingival calculus.
P3：Remove the subgingival and perio deep calculus
P4：Remove subgingical and deep perio calculus.
E1: 120°Angle Holder for Shank dia:0.8mm U files,usually use for anterior root canal cleaning, sterilizing and taking out the stem in root canal.
E2: 95° Angle Holder for Shank dia :0.8mm U files,usually use for molar root canal cleaning,sterilizing and taking out the stem in root canal.
E3: After root canal cleaning, using the mech-anism and heat energy of ultrasonic vibration to intenerate the filling Lateral condensation, to make sure the top of the scaler tip touch the lateral condensation.
Statement
(FDA, ARTG): 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, please 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.
Payment:
Paypal only
Shipping Terms:
1. International Shipping to worldwide.
2. Handling within 24 business hours.
3. Tracking info of your parcel is available.
4. Returns could be accepted within 30 days after receipt of the item.
5. 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.
Refund or replacement request is available only the requests within 1 week after parcel received & returning the item as the same condition as received.
We work at 8:30am to 18:00pm Beijing Time.
Please contact us through ebay message if there is a query, we will reply you within 24 hours in working days. Thank you!
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