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 Sirona Dental Systems GmbH.

286
Total
286
Cleared
141d
Avg days
1977
Since
286 devices
73–96 of 286
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 Apr 21, 2004
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
K040117
Arrow Industries, LLC
Dental · 92d
Cleared Apr 20, 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
K040116
Dxm Co., Ltd.
Dental · 91d
Cleared Apr 07, 2004
BIOFREE
K033925
Dental Components, Inc.
Dental · 111d
Cleared Mar 23, 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
K040691
Win-Us Technology Co., Ltd.
Dental · 6d
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 30, 2003
STERISIL ANTIMICROBIAL TUBING AND BOTTLE
K031681
Sterisil
Dental · 153d
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 Aug 25, 2003
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
K032341
Sota Precision Optics, Inc.
Dental · 27d
Cleared Jun 19, 2003
C-1805M
K023815
Anodia Systems
Dental · 216d
Cleared Jun 19, 2003
C-1890
K023896
Anodia Systems
Dental · 209d
Cleared Mar 26, 2003
LOGOS JUNIOR DENTAL CHAIR AND UNIT
K023513
Castellini S.P.A.
Dental · 156d
Cleared Jan 16, 2003
RDH-2000
K023213
Anodia Systems
Dental · 112d
Cleared Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217
Aseptico, Inc.
Dental · 108d
Cleared Aug 30, 2002
VERACAM
K021083
Lumalite, Inc.
Dental · 149d
Cleared Aug 08, 2002
BOYD DELIVERY UNIT
K020833
Boyd Industries, Inc.
Dental · 147d
Cleared Jun 13, 2002
ORACAM
K020957
Video Dental Concepts, Inc.
Dental · 80d
Cleared Apr 11, 2002
INTRAORAL CAMERA ME-15
K020206
Dent Corp. Research & Development
Dental · 79d