FDA Product Code LBH: Varnish, Cavity
Leading manufacturers include Ultradent Products, Inc., Kettenbach GmbH & Co. KG and Belport Company, Inc., Gingi-Pak.
FDA 510(k) Cleared Varnish, Cavity Devices (Product Code LBH)
About Product Code LBH - Regulatory Context
510(k) Submission Activity
137 total 510(k) submissions under product code LBH since 1976, with 137 receiving FDA clearance (average review time: 126 days).
Submission volume has increased in recent years - 10 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 LBH have taken an average of 190 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
LBH devices are reviewed by the Dental panel. Browse all Dental devices →