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 Air Techniques, Inc..

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
49–72 of 285
Cleared Nov 02, 2005
ABSOLUTE AMERICA
K050571
Eurodent S.P.A.
Dental · 243d
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
Cleared Sep 21, 2004
MICROSCOPE SYSTEM
K041805
Miras Mirror Imaging Solutions, Ltd.
Dental · 77d
Cleared Aug 24, 2004
MARE DENTAL OPERATIVE UNIT
K041458
Denimed Electronica S.H.
Dental · 84d
Cleared Aug 19, 2004
COCOON HYGIENIST
K040529
Satelec
Dental · 171d
Cleared Feb 02, 2004
STV PRO 2
K033419
Trophy Radiologie
Dental · 98d
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 Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217
Aseptico, Inc.
Dental · 108d
Cleared Oct 05, 2001
SOPRO595 INTRA ORAL CAMERA
K012505
Sopro
Dental · 63d
Cleared Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090
Midmark Corp.
Dental · 15d
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 Sep 08, 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
K992893
Mrlb Intl., Inc.
Dental · 12d