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