FDA Product Code EIA: Unit, Operative Dental
FDA product code EIA covers operative dental units that integrate all components needed for dental treatment at a single patient chair.
These self-contained units combine delivery systems for air, water, suction, and instrument connections with an adjustable patient chair and operator's stool, providing the complete infrastructure for dental examination and treatment in a single integrated station.
EIA devices are Class I medical devices, regulated under 21 CFR 872.6640 and reviewed by the FDA Dental panel.
Leading manufacturers include A-Dec, Inc., Aseptico, Inc. and Ace Surgical Supply Co., Inc..
285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
Cleared
Dec 08, 2016
ESTETICA Dental Treatment Unit and Accessories
Kaltenbach & Voigt GmbH
Dental
190d
Cleared
Jan 22, 2016
TAURUS C1
Shinhung Company, Ltd.
Dental
186d
Cleared
Jan 22, 2016
Evogue Dental Unit
Takara Belmont Corporation
Dental
178d
Cleared
Sep 18, 2015
Spirit
Pelton & Crane
Dental
268d
Cleared
Jul 24, 2015
TENEO Dental Treatment Unit and Accessories
Sirona Dental Systems GmbH
Dental
95d
Cleared
Jul 17, 2015
INTEGO Family and Accesories
Sirona Dental Systems GmbH
Dental
105d
Cleared
Apr 17, 2015
UnicLine Mobile
Heka Dental A/S
Dental
51d
Cleared
Mar 13, 2015
Dental Unit
Zhuhai Siger Medical Equipment Co., Ltd.
Dental
214d
Cleared
Feb 24, 2015
T-8000 THEROZONE UNIT
Therozone USA, Inc.
Dental
263d
Cleared
Jan 08, 2015
S200, S300
Cefla S.C.
Dental
427d
Cleared
Sep 05, 2014
AJAX DENTAL UNIT
Pro Dental Services, LLC
Dental
414d
Cleared
Apr 18, 2014
ERGONOMIC PRODUCTS WORKSTATION
Ergonomic Products, Inc.
Dental
267d
Cleared
Oct 30, 2013
DIPLOMAT
Diplomat Dental S.R.O.
Dental
243d
Cleared
Jul 26, 2013
DENTAL UNIT WITH CHAIR
Xianyang North West Medical Instrument (Group) Co.
Dental
157d
Cleared
Aug 24, 2012
ELEVANCE
Midmark
Dental
211d
Cleared
Apr 05, 2012
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
Asi Medical, Inc.
Dental
412d
Cleared
Dec 02, 2011
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
Shanghai Dynamic Industry Co., Ltd.
Dental
150d
Cleared
Nov 10, 2011
CS 1200
Carestream Health, Inc.
Dental
90d
Cleared
Apr 11, 2011
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
Aseptico, Inc.
Dental
334d
Cleared
Jan 04, 2011
YOBOSHI DENTAL UNIT
Fosham Yoboshi Medical Equipment Co., Ltd.
Dental
32d
Cleared
Nov 24, 2010
A-DEC 200 DENTAL SYSTEM
A-Dec, Inc.
Dental
107d
Cleared
Jun 24, 2010
STERN'S S250 NORDAM
Cefla S.C.
Dental
275d
Cleared
Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
Carestream Health, Inc.
Dental
117d
Cleared
Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
A-Dec, Inc.
Dental
71d