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
Sep 26, 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
Sds Dental, Inc.
Dental
49d
Cleared
Sep 25, 1986
CABINET II AUXILIARY UNIT
Sds Dental, Inc.
Dental
48d
Cleared
Aug 04, 1980
SPACELINE DENTAL CHAIR-UNIT
Pacific Dental Corp.
Dental
14d
Cleared
Feb 26, 1979
MOBILE UNITS, I,II,III,IV
Dentsply Intl.
Dental
38d