FDA Product Code EBC: Sealant, Pit And Fissure, And Conditioner
Leading manufacturers include Rizhao Huge Biomaterials Company, Ltd., Parkell, Inc. and Mediclus Co., Ltd..
FDA 510(k) Cleared Sealant, Pit And Fissure, And Conditioner Devices (Product Code EBC)
About Product Code EBC - Regulatory Context
510(k) Submission Activity
131 total 510(k) submissions under product code EBC since 1976, with 131 receiving FDA clearance (average review time: 81 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under EBC have taken an average of 173 days to reach a decision - up from 79 days historically. Manufacturers should account for longer review timelines in current project planning.
EBC devices are reviewed by the Dental panel. Browse all Dental devices →