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
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