EIA · Class I · 21 CFR 872.6640

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
49–72 of 286
Cleared Jun 24, 2010
STERN'S S250 NORDAM
K092917
Cefla S.C.
Dental · 275d
Cleared Sep 29, 2009
MODEL GDCH-2000
K092851
Global Dental Direct, Inc.
Dental · 13d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186
Carestream Health, Inc.
Dental · 117d
Cleared May 01, 2009
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
K090079
Progeny, Inc.
Dental · 109d
Cleared Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
K082985
A-Dec, Inc.
Dental · 71d
Cleared Aug 29, 2008
PLANMECA SOVEREIGN
K081699
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
K081237
Craftmaster Contour Equipment, Inc.
Dental · 116d
Cleared Aug 22, 2008
WESTAR SERIES DENTAL UNITS
K082294
Westar Medical Products, Inc.
Dental · 10d
Cleared Jun 06, 2008
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
K080677
Kaltenbach & Voigt GmbH & Co.
Dental · 88d
Cleared Apr 04, 2008
DENTAL UNIT WITH CHAIR
K080438
North West Medical Instrument (Group) Co., Ltd.
Dental · 45d
Cleared Aug 28, 2007
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
K071485
Tpc Advanced Technology, Inc.
Dental · 90d
Cleared Mar 07, 2007
OPTI
K063646
Camsight Co., Inc.
Dental · 90d
Cleared Jan 26, 2007
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
K070196
Hr Dental Products, Inc.
Dental · 4d
Cleared Dec 14, 2006
C-U2
K062897
Cefla S.C.R.L.
Dental · 78d
Cleared Nov 15, 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302
Shanghai Dental Instrument Factory
Dental · 14d
Cleared Jul 17, 2006
COMPACT PLUS - EXTREME - PERFECT PLUS
K052574
J.O. Suarez & Cia, Ltda
Dental · 301d
Cleared May 23, 2006
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
K061175
Sota Precision Optics, Inc.
Dental · 26d
Cleared Nov 02, 2005
ABSOLUTE AMERICA
K050571
Eurodent S.P.A.
Dental · 243d
Cleared Nov 01, 2005
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
K052470
Shanghai Fimet Medical Instrument Co., Ltd.
Dental · 54d
Cleared Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
K051657
A-Dec, Inc.
Dental · 70d
Cleared Mar 18, 2005
AEU-14CF EXPENDITION
K050201
Aseptico, Inc.
Dental · 49d
Cleared Feb 16, 2005
SPACELINE EMCIA, MODEL CU580
K043496
J. Morita USA, Inc.
Dental · 61d
Cleared Feb 11, 2005
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
K043325
Rolence Enteprise, Inc.
Dental · 71d
Cleared Oct 20, 2004
OPTIMA MX
K042759
Bien-Air SA Switzerland
Dental · 15d