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 Sds Dental, Inc..

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
121–144 of 285
Cleared Jul 03, 1997
PURE COMPANY FLUID DELIVERY SYSTEM
K971278
Pure Co.
Dental · 87d
Cleared Jul 03, 1997
PEFECT SHOT
K972019
International Imaging Electronics
Dental · 32d
Cleared Jun 20, 1997
PLANMECA INTRACAM
K972033
Planmeca Oy
Dental · 18d
Cleared Jun 19, 1997
INFECTION CONTROL CARTRIDGE
K964942
Dentalpure Corp.
Dental · 191d
Cleared May 23, 1997
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
K971100
Atrion Medical Products, Inc.
Dental · 58d
Cleared May 14, 1997
ODYSSEY I DENTAL WATER UNIT
K964796
Germiphene Corp.
Dental · 166d
Cleared Apr 04, 1997
EASY CAM
K970626
I.C.S.
Dental · 44d
Cleared Mar 05, 1997
STERILE WATER PUMP
K970002
Micro Motors, Inc.
Dental · 62d
Cleared Jan 22, 1997
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
K963548
Mrlb Intl., Inc.
Dental · 139d
Cleared Jan 22, 1997
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K964619
Sds Dental, Inc.
Dental · 65d
Cleared Nov 22, 1996
CDR-CAM
K963778
Schick Technologies, Inc.
Dental · 63d
Cleared Sep 10, 1996
PROSTYLE COMPACT
K961420
Planmeca Oy
Dental · 151d
Cleared Aug 22, 1996
A-DEC SELF-CONTAINED WATER SYSTEM
K962665
A-Dec, Inc.
Dental · 44d
Cleared Aug 06, 1996
SPIRIT S1/S2
K962071
Pelton & Crane Co.
Dental · 70d
Cleared Aug 01, 1996
GENERAL PURPOSE DENTAL TRAY
K962527
Medcare Medical Group, Inc.
Dental · 35d
Cleared Jun 12, 1996
PORTA'PURE/DENTAL
K961409
Water Solution Technologies
Dental · 62d
Cleared May 08, 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556
Scitech Solutions, Inc.
Dental · 89d
Cleared Apr 15, 1996
POWERS ANTI-BACTERIAL VALVE
K954471
Powers Dental & Medical Technology, Inc.
Dental · 202d
Cleared Mar 25, 1996
A-DEC PERFORMER CONTROL UNIT
K960506
A-Dec, Inc.
Dental · 49d
Cleared Sep 19, 1995
STOMAVISION (STV)
K951074
Trophy Radiologie
Dental · 194d
Cleared May 10, 1995
INTRAORAL VIDEO SCOPE AND WINDOW TUBE
K951019
Cuda Products Co.
Dental · 64d
Cleared Mar 17, 1995
VACSTAR
K942698
Air Techniques, Inc.
Dental · 282d
Cleared Mar 16, 1995
VISTACAM
K943204
Air Techniques, Inc.
Dental · 254d
Cleared Jul 26, 1994
DENTAL TRAY
K941349
Cush Medical Products
Dental · 127d