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., W&H Dentalwerk Buermoos GmbH and Micro-Nx Co., Ltd..
62
Total
62
Cleared
213d
Avg days
1977
Since
62 devices
Cleared
May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
W&H Dentalwerk Buermoos GmbH
Dental
144d
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
Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
W&H Dentalwerk Buermoos GmbH
Dental
180d
Cleared
Feb 03, 2000
PRO-TORQ
Micro Motors, Inc.
Dental
16d
Cleared
Jan 31, 2000
ROTARY MASTER
J. Morita USA, Inc.
Dental
178d
Cleared
Jun 09, 1999
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
Nsk Nakanishi, Inc.
Dental
79d
Cleared
Jan 22, 1998
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
W & H Dentalwerk
Dental
170d
Cleared
Oct 30, 1997
SURGIC II IMPLANT CONTROL UNIT
Nsk Nakanishi, Inc.
Dental
83d
Cleared
Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
Bell Intl., Inc.
Dental
89d
Cleared
Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
Bell Intl., Inc.
Dental
86d
Cleared
Feb 27, 1991
MODIFIED SITE PERISTALTIC FOOTSWITCH
Site Microsurgical Systems, Inc.
Dental
75d
Cleared
May 14, 1979
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
Applied Medical Research
Dental
88d
Cleared
Jan 28, 1977
SPRINT S-2 INSTRU. CENTER (MODEL 92329)
Chemetron Health Systems
Dental
7d