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 Air Techniques, Inc..
285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
Cleared
Nov 02, 2005
ABSOLUTE AMERICA
Eurodent S.P.A.
Dental
243d
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
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
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 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
Dentsply Intl.
Dental
27d
Cleared
Aug 27, 2003
ELCACAM
A-Dec, Inc.
Dental
55d
Cleared
Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
Aseptico, Inc.
Dental
108d
Cleared
Oct 05, 2001
SOPRO595 INTRA ORAL CAMERA
Sopro
Dental
63d
Cleared
Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
Midmark Corp.
Dental
15d
Cleared
May 03, 2000
4631 DUO DELIVERY SYSTEM
A-Dec, Inc.
Dental
37d
Cleared
May 03, 2000
4635 ASSISTANT'S INSTRUMENTATION
A-Dec, Inc.
Dental
37d
Cleared
May 03, 2000
3181 DUO DELIVERY SYSTEM
A-Dec, Inc.
Dental
37d
Cleared
Apr 13, 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
Dentsply Intl.
Dental
90d
Cleared
Oct 08, 1999
QUANTEC-E IRRIGATION SYSTEM 2
Sybron Dental Specialties, Inc.
Dental
101d
Cleared
Sep 08, 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
Mrlb Intl., Inc.
Dental
12d