FDA Product Code EBW: Controller, Foot, Handpiece And Cord
FDA product code EBW covers foot controllers, dental handpiece bodies, and cords used as accessories in dental procedures.
These components enable hands-free speed control of dental handpieces through foot pedal activation, allowing the clinician to adjust rotational speed without removing hands from the operative field. They are used with air-driven and electric dental handpiece systems.
EBW devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.
Leading manufacturers include Nakanishi, Inc., Micro-Nx Co., Ltd. and Saeshin Precision Co., Ltd..
61
Total
61
Cleared
212d
Avg days
1977
Since
61 devices
Cleared
May 28, 2014
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
A-Dec, Inc.
Dental
167d
Cleared
May 26, 2011
E3 TORQUE CONTROL MOTOR
Dentsply International, Inc.
Dental
164d
Cleared
Dec 03, 2003
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
A-Dec, Inc.
Dental
105d
Cleared
Aug 19, 2003
SIROTORQUE L
Sirona Dental Systems GmbH
Dental
90d
Cleared
Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
Nakanishi, Inc.
Dental
67d
Cleared
Sep 11, 2001
ELEC-MATE E
Nakanishi, Inc.
Dental
83d
Cleared
Jan 31, 2000
ROTARY MASTER
J. Morita USA, Inc.
Dental
178d