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.

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
145–168 of 285
Cleared Jul 12, 1994
A-DEC RADIUS 2122/2132
K940893
A-Dec, Inc.
Dental · 137d
Cleared May 16, 1994
KAVO INTRASEPT 905
K934783
Kavo America
Dental · 222d
Cleared Apr 21, 1994
A-DEC CASCADE 3072 WALLMOUNT
K935325
A-Dec, Inc.
Dental · 167d
Cleared Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK II
K922649
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE DENTAL IMPLANT CUSTOM SURGICAL PACK
K922650
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE DENTAL IMPLANT KIT
K922651
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK I
K922652
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 06, 1994
A-DEC 2544 DOCTORS IC MICRO-CART
K925797
A-Dec, Inc.
Dental · 416d
Cleared Jan 06, 1994
A-DEC 2545 DUO IC MICRO-CART
K925798
A-Dec, Inc.
Dental · 416d
Cleared Oct 20, 1993
A-DEC 2611 ASSISTANT'S CART
K933166
A-Dec, Inc.
Dental · 113d
Cleared Oct 13, 1993
A-DEC 2912 DUO CART
K933167
A-Dec, Inc.
Dental · 106d
Cleared Oct 12, 1993
A-DEC 2612 ASSISTANT'S CART
K933163
A-Dec, Inc.
Dental · 105d
Cleared Oct 12, 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165
A-Dec, Inc.
Dental · 105d
Cleared Oct 12, 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168
A-Dec, Inc.
Dental · 105d
Cleared Nov 13, 1991
MDT/CASTLE PURUS DENTAL UNIT
K914697
Mdt Corp., Inc.
Dental · 26d
Cleared Feb 20, 1991
ASEPTIMINI UNIT, ADU-10
K905401
Aseptico, Inc.
Dental · 79d
Cleared Jan 31, 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011
Concord/Portex
Dental · 85d
Cleared Oct 24, 1990
A-DEC PAC I PORTABLE UNIT
K903451
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC IC CONTROL HEAD
K903452
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC IC MICRO-CART
K903453
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC DECADE CUSPIDOR
K903455
A-Dec, Inc.
Dental · 85d
Cleared Aug 15, 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806
Sage Products, Inc.
Dental · 117d
Cleared Dec 08, 1988
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526
Aseptico, Inc.
Dental · 191d
Cleared Oct 01, 1986
CM-II, CM-I WATER UNIT
K863021
Sds Dental, Inc.
Dental · 54d