FDA for Handpiece:
510(K) Number: K181691,
Regulation Number: 872.4200,
Classification Product Code: EFB,
Subsequent Product Code: EGS
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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
Low Speed Handpiece
Straight Nose Cone:
- Working pressure: 0.25MPa (4-hole)
- 0.25MPa (4-hole) (Measure meter is installed at the end of air motor to measure the air pressure).
- Revolution: about 22000-27000r/min (adjustable between clockwise or anticlockwise)- Noise: ≤70dB
Air Mortor:
- Supply air pressure: 245-392KPa (2.5-4kgf/CM2)
- 1:1 Direct Drive
- 4 holes
We commited ourselves to your 100% satisfaction both with our goods and services.
1. Please leave me FIVE star POSITIVE feedback if you are satisfied with our items.
2. Please CONTACT me immediately before leave us neutral feedback or negtive feedback, We will try our best to resolve any problem for you untill you are satisfied.
Notice:
1. Import duties, taxes and charges are not included in the item price or shipping charges. These charges are the buyer’s responsibility.
2. Please check your country’s customs office to determine what these additional costs will be prior to bidding/buying.
Warmly remind:
Pls let me know before taking any action, because your action will has an important impact on our shop.
So pls give me a chance to offer the best sollution for you!!
Our working time:
Monday - Friday 9:00 AM - 5:30PM (Beijing)
Return & Refund:
Return within 30 days is accepted, though the item in good condition.
The following FDA Disclaimer is required for all eBay listing in healthcare category: 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.)
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