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 Megagen Implant Co., Ltd., Osstem Implant Co., Ltd. Chair Business and Bdc Dental Corporation , Ltd..
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 Review Time
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 →