- LED Scaler Handpiece ：
- 1. Brand New; Durable; 100% CE High Quality.
- 2. It will be applied to build LED Light source inside the handpiece to help doctors see more clearly in the course of the treatment,precise operation
- 3. Detachable handpiece can be 135 centigrade and 0.22MPa autoclave sterilization and to effectively prevent cross-infection
- 4. Compatible with EMS Ultrasonic Dental Scaler.
- 5. Widely used by worldwide dentists with positive feedbacks.
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