FDA Product Code EBD: Coating, Filling Material, Resin
Leading manufacturers include Id Korea Co., Ltd., YAMAHACHI DENTAL MFG., Co. and Bredent GmbH & Co. KG.
FDA 510(k) Cleared Coating, Filling Material, Resin Devices (Product Code EBD)
About Product Code EBD - Regulatory Context
510(k) Submission Activity
52 total 510(k) submissions under product code EBD since 1976, with 52 receiving FDA clearance (average review time: 87 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EBD have taken an average of 152 days to reach a decision - up from 83 days historically. Manufacturers should account for longer review timelines in current project planning.
EBD devices are reviewed by the Dental panel. Browse all Dental devices →