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., Sirona Dental Systems GmbH and Dentsply Intl..
284
Total
284
Cleared
140d
Avg days
1977
Since
284 devices
Cleared
Nov 10, 2011
CS 1200
Carestream Health, Inc.
Dental
90d
Cleared
Nov 24, 2010
A-DEC 200 DENTAL SYSTEM
A-Dec, Inc.
Dental
107d
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
Cleared
Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
A-Dec, Inc.
Dental
70d
Cleared
Feb 16, 2005
SPACELINE EMCIA, MODEL CU580
J. Morita USA, Inc.
Dental
61d
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
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
Jun 24, 1999
QUANTEC-E IRRIGATION SYSTEM
Sybron Dental Specialties, Inc.
Dental
87d
Cleared
Dec 11, 1998
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
Sirona Dental Systems GmbH
Dental
86d
Cleared
Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
KARL STORZ Endoscopy-America, Inc.
Dental
77d
Cleared
Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
Welch Allyn, Inc.
Dental
83d
Cleared
Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
Trinity Laboratories, Inc.
Dental
84d
Cleared
Aug 22, 1996
A-DEC SELF-CONTAINED WATER SYSTEM
A-Dec, Inc.
Dental
44d
Cleared
Mar 25, 1996
A-DEC PERFORMER CONTROL UNIT
A-Dec, Inc.
Dental
49d
Cleared
Jul 12, 1994
A-DEC RADIUS 2122/2132
A-Dec, Inc.
Dental
137d