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
Sep 21, 2004
MICROSCOPE SYSTEM
Miras Mirror Imaging Solutions, Ltd.
Dental
77d
Cleared
Aug 24, 2004
MARE DENTAL OPERATIVE UNIT
Denimed Electronica S.H.
Dental
84d
Cleared
Aug 19, 2004
COCOON HYGIENIST
Satelec
Dental
171d
Cleared
Apr 21, 2004
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
Arrow Industries, LLC
Dental
92d
Cleared
Apr 20, 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
Dxm Co., Ltd.
Dental
91d
Cleared
Apr 07, 2004
BIOFREE
Dental Components, Inc.
Dental
111d
Cleared
Mar 23, 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
Win-Us Technology Co., Ltd.
Dental
6d
Cleared
Feb 02, 2004
STV PRO 2
Trophy Radiologie
Dental
98d
Cleared
Dec 10, 2003
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
A-Dec, Inc.
Dental
96d
Cleared
Dec 04, 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
A-Dec, Inc.
Dental
90d
Cleared
Nov 14, 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
Sirona Dental Systems GmbH
Dental
88d
Cleared
Oct 30, 2003
STERISIL ANTIMICROBIAL TUBING AND BOTTLE
Sterisil
Dental
153d
Cleared
Oct 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
Dentsply Intl.
Dental
27d
Cleared
Aug 27, 2003
ELCACAM
A-Dec, Inc.
Dental
55d
Cleared
Aug 25, 2003
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
Sota Precision Optics, Inc.
Dental
27d
Cleared
Jun 19, 2003
C-1805M
Anodia Systems
Dental
216d
Cleared
Jun 19, 2003
C-1890
Anodia Systems
Dental
209d
Cleared
Mar 26, 2003
LOGOS JUNIOR DENTAL CHAIR AND UNIT
Castellini S.P.A.
Dental
156d
Cleared
Jan 16, 2003
RDH-2000
Anodia Systems
Dental
112d
Cleared
Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
Aseptico, Inc.
Dental
108d
Cleared
Aug 30, 2002
VERACAM
Lumalite, Inc.
Dental
149d
Cleared
Aug 08, 2002
BOYD DELIVERY UNIT
Boyd Industries, Inc.
Dental
147d
Cleared
Jun 13, 2002
ORACAM
Video Dental Concepts, Inc.
Dental
80d
Cleared
Apr 11, 2002
INTRAORAL CAMERA ME-15
Dent Corp. Research & Development
Dental
79d