FDA for Handpiece:
510(K) Number: K181691,
Regulation Number: 872.4200,
Classification Product Code: EFB,
Subsequent Product Code: EGS
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Description:
Power:100-240V 50/60Hz
With 3-speed settings: 500、1500、2500rpm/min
Torque range:>1.5N.cm
Compatible with all universal disposable prophy angles
Ergonomic design provides perfect balance
Operate comfortable and flexible
For teeth cleaning and polishing
Package:
Main unit 1pc
Disposable materials 2pcs
Adapter 1pc
USB cable 1pc
Base 1pc
Notes:Delivery belt 2 disposable prophy angles
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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
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.
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