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., Sirona Dental Systems GmbH and Dentsply Intl..

284
Total
284
Cleared
140d
Avg days
1977
Since
284 devices
25–48 of 284
Cleared Nov 10, 2011
CS 1200
K112321
Carestream Health, Inc.
Dental · 90d
Cleared Nov 24, 2010
A-DEC 200 DENTAL SYSTEM
K102234
A-Dec, Inc.
Dental · 107d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186
Carestream Health, Inc.
Dental · 117d
Cleared Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
K082985
A-Dec, Inc.
Dental · 71d
Cleared Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
K051657
A-Dec, Inc.
Dental · 70d
Cleared Feb 16, 2005
SPACELINE EMCIA, MODEL CU580
K043496
J. Morita USA, Inc.
Dental · 61d
Cleared Dec 10, 2003
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757
A-Dec, Inc.
Dental · 96d
Cleared Dec 04, 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756
A-Dec, Inc.
Dental · 90d
Cleared Nov 14, 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
K032543
Sirona Dental Systems GmbH
Dental · 88d
Cleared Oct 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904
Dentsply Intl.
Dental · 27d
Cleared Aug 27, 2003
ELCACAM
K032070
A-Dec, Inc.
Dental · 55d
Cleared May 03, 2000
4631 DUO DELIVERY SYSTEM
K000966
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
4635 ASSISTANT'S INSTRUMENTATION
K000967
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
3181 DUO DELIVERY SYSTEM
K000968
A-Dec, Inc.
Dental · 37d
Cleared Apr 13, 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112
Dentsply Intl.
Dental · 90d
Cleared Oct 08, 1999
QUANTEC-E IRRIGATION SYSTEM 2
K992195
Sybron Dental Specialties, Inc.
Dental · 101d
Cleared Jun 24, 1999
QUANTEC-E IRRIGATION SYSTEM
K991035
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Dec 11, 1998
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242
Sirona Dental Systems GmbH
Dental · 86d
Cleared Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658
KARL STORZ Endoscopy-America, Inc.
Dental · 77d
Cleared Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937
Welch Allyn, Inc.
Dental · 83d
Cleared Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238
Trinity Laboratories, Inc.
Dental · 84d
Cleared Aug 22, 1996
A-DEC SELF-CONTAINED WATER SYSTEM
K962665
A-Dec, Inc.
Dental · 44d
Cleared Mar 25, 1996
A-DEC PERFORMER CONTROL UNIT
K960506
A-Dec, Inc.
Dental · 49d
Cleared Jul 12, 1994
A-DEC RADIUS 2122/2132
K940893
A-Dec, Inc.
Dental · 137d