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 Sirona Dental Systems GmbH.
286
Total
286
Cleared
141d
Avg days
1977
Since
286 devices
Cleared
Jun 24, 2010
STERN'S S250 NORDAM
Cefla S.C.
Dental
275d
Cleared
Sep 29, 2009
MODEL GDCH-2000
Global Dental Direct, Inc.
Dental
13d
Cleared
Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
Carestream Health, Inc.
Dental
117d
Cleared
May 01, 2009
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
Progeny, Inc.
Dental
109d
Cleared
Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
A-Dec, Inc.
Dental
71d
Cleared
Aug 29, 2008
PLANMECA SOVEREIGN
Planmeca USA, Inc.
Dental
73d
Cleared
Aug 25, 2008
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
Craftmaster Contour Equipment, Inc.
Dental
116d
Cleared
Aug 22, 2008
WESTAR SERIES DENTAL UNITS
Westar Medical Products, Inc.
Dental
10d
Cleared
Jun 06, 2008
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
Kaltenbach & Voigt GmbH & Co.
Dental
88d
Cleared
Apr 04, 2008
DENTAL UNIT WITH CHAIR
North West Medical Instrument (Group) Co., Ltd.
Dental
45d
Cleared
Aug 28, 2007
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
Tpc Advanced Technology, Inc.
Dental
90d
Cleared
Mar 07, 2007
OPTI
Camsight Co., Inc.
Dental
90d
Cleared
Jan 26, 2007
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
Hr Dental Products, Inc.
Dental
4d
Cleared
Dec 14, 2006
C-U2
Cefla S.C.R.L.
Dental
78d
Cleared
Nov 15, 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
Shanghai Dental Instrument Factory
Dental
14d
Cleared
Jul 17, 2006
COMPACT PLUS - EXTREME - PERFECT PLUS
J.O. Suarez & Cia, Ltda
Dental
301d
Cleared
May 23, 2006
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
Sota Precision Optics, Inc.
Dental
26d
Cleared
Nov 02, 2005
ABSOLUTE AMERICA
Eurodent S.P.A.
Dental
243d
Cleared
Nov 01, 2005
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
Shanghai Fimet Medical Instrument Co., Ltd.
Dental
54d
Cleared
Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
A-Dec, Inc.
Dental
70d
Cleared
Mar 18, 2005
AEU-14CF EXPENDITION
Aseptico, Inc.
Dental
49d
Cleared
Feb 16, 2005
SPACELINE EMCIA, MODEL CU580
J. Morita USA, Inc.
Dental
61d
Cleared
Feb 11, 2005
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
Rolence Enteprise, Inc.
Dental
71d
Cleared
Oct 20, 2004
OPTIMA MX
Bien-Air SA Switzerland
Dental
15d