FDA Product Code EBZ: Activator, Ultraviolet, For Polymerization
Leading manufacturers include Ultradent Products, Inc., Foshan Coxo Medical Instrument Co., Ltd. and Premium Plus (Dongguan) Limited.
FDA 510(k) Cleared Activator, Ultraviolet, For Polymerization Devices (Product Code EBZ)
About Product Code EBZ - Regulatory Context
510(k) Submission Activity
213 total 510(k) submissions under product code EBZ since 1977, with 213 receiving FDA clearance (average review time: 94 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under EBZ have taken an average of 115 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.
EBZ devices are reviewed by the Dental panel. Browse all Dental devices →