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.
285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
Cleared
Jul 12, 1994
A-DEC RADIUS 2122/2132
A-Dec, Inc.
Dental
137d
Cleared
May 16, 1994
KAVO INTRASEPT 905
Kavo America
Dental
222d
Cleared
Apr 21, 1994
A-DEC CASCADE 3072 WALLMOUNT
A-Dec, Inc.
Dental
167d
Cleared
Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK II
Ace Surgical Supply Co., Inc.
Dental
586d
Cleared
Jan 10, 1994
ACE DENTAL IMPLANT CUSTOM SURGICAL PACK
Ace Surgical Supply Co., Inc.
Dental
586d
Cleared
Jan 10, 1994
ACE DENTAL IMPLANT KIT
Ace Surgical Supply Co., Inc.
Dental
586d
Cleared
Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK I
Ace Surgical Supply Co., Inc.
Dental
586d
Cleared
Jan 06, 1994
A-DEC 2544 DOCTORS IC MICRO-CART
A-Dec, Inc.
Dental
416d
Cleared
Jan 06, 1994
A-DEC 2545 DUO IC MICRO-CART
A-Dec, Inc.
Dental
416d
Cleared
Oct 20, 1993
A-DEC 2611 ASSISTANT'S CART
A-Dec, Inc.
Dental
113d
Cleared
Oct 13, 1993
A-DEC 2912 DUO CART
A-Dec, Inc.
Dental
106d
Cleared
Oct 12, 1993
A-DEC 2612 ASSISTANT'S CART
A-Dec, Inc.
Dental
105d
Cleared
Oct 12, 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
A-Dec, Inc.
Dental
105d
Cleared
Oct 12, 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
A-Dec, Inc.
Dental
105d
Cleared
Nov 13, 1991
MDT/CASTLE PURUS DENTAL UNIT
Mdt Corp., Inc.
Dental
26d
Cleared
Feb 20, 1991
ASEPTIMINI UNIT, ADU-10
Aseptico, Inc.
Dental
79d
Cleared
Jan 31, 1991
ORAL PHARYNGEAL CLEANSING DEVICE
Concord/Portex
Dental
85d
Cleared
Oct 24, 1990
A-DEC PAC I PORTABLE UNIT
A-Dec, Inc.
Dental
85d
Cleared
Oct 24, 1990
A-DEC IC CONTROL HEAD
A-Dec, Inc.
Dental
85d
Cleared
Oct 24, 1990
A-DEC IC MICRO-CART
A-Dec, Inc.
Dental
85d
Cleared
Oct 24, 1990
A-DEC DECADE CUSPIDOR
A-Dec, Inc.
Dental
85d
Cleared
Aug 15, 1990
SUCTION ORA-SWAB(R) BRUSH KIT
Sage Products, Inc.
Dental
117d
Cleared
Dec 08, 1988
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
Aseptico, Inc.
Dental
191d
Cleared
Oct 01, 1986
CM-II, CM-I WATER UNIT
Sds Dental, Inc.
Dental
54d