EBW · Class I · 21 CFR 872.4200

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
49–62 of 62
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
K020327
Nakanishi, Inc.
Dental · 67d
Cleared Sep 11, 2001
ELEC-MATE E
K011926
Nakanishi, Inc.
Dental · 83d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469
W&H Dentalwerk Buermoos GmbH
Dental · 180d
Cleared Feb 03, 2000
PRO-TORQ
K000120
Micro Motors, Inc.
Dental · 16d
Cleared Jan 31, 2000
ROTARY MASTER
K992648
J. Morita USA, Inc.
Dental · 178d
Cleared Jun 09, 1999
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
K990954
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)
K972889
W & H Dentalwerk
Dental · 170d
Cleared Oct 30, 1997
SURGIC II IMPLANT CONTROL UNIT
K972924
Nsk Nakanishi, Inc.
Dental · 83d
Cleared Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860
Bell Intl., Inc.
Dental · 89d
Cleared Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
K964863
Bell Intl., Inc.
Dental · 86d
Cleared Feb 27, 1991
MODIFIED SITE PERISTALTIC FOOTSWITCH
K905620
Site Microsurgical Systems, Inc.
Dental · 75d
Cleared May 14, 1979
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322
Applied Medical Research
Dental · 88d
Cleared Jan 28, 1977
SPRINT S-2 INSTRU. CENTER (MODEL 92329)
K770129
Chemetron Health Systems
Dental · 7d