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..
FDA 510(k) Cleared Unit, Operative Dental Devices (Product Code EIA)
About Product Code EIA - Regulatory Context
510(k) Submission Activity
284 total 510(k) submissions under product code EIA since 1977, with 284 receiving FDA clearance (average review time: 140 days).
Submission volume has remained relatively stable over the observed period, with 8 submissions in the last 24 months.
FDA 510(k) Review Time - EIA Product Code
Recent submissions under EIA have taken an average of 264 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
EIA devices are reviewed by the Dental panel. Browse all Dental devices →