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., Sirona Dental Systems GmbH and Dentsply Intl..
284
Total
284
Cleared
140d
Avg days
1977
Since
284 devices
Cleared
Apr 21, 1994
A-DEC CASCADE 3072 WALLMOUNT
A-Dec, Inc.
Dental
167d
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
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
Feb 26, 1979
MOBILE UNITS, I,II,III,IV
Dentsply Intl.
Dental
38d