FDA Product Code EBG: Crown And Bridge, Temporary, Resin
Leading manufacturers include Rizhao Huge Biomaterials Company, Ltd., Liaoning Upcera Co., Ltd. and Hangzhou SHINING3D Dental Technology Co., Ltd..
FDA 510(k) Cleared Crown And Bridge, Temporary, Resin Devices (Product Code EBG)
About Product Code EBG - Regulatory Context
510(k) Submission Activity
189 total 510(k) submissions under product code EBG since 1977, with 189 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EBG have taken an average of 142 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
EBG devices are reviewed by the Dental panel. Browse all Dental devices →