FDA Product Code LQY: Locator, Root Apex
Leading manufacturers include Cefla S.C., Shenzhen Rogin Medical Co., Ltd. and SHENZHEN SUPERLINE TECHNOLOGY CO., LTD..
FDA 510(k) Cleared Locator, Root Apex Devices (Product Code LQY)
About Product Code LQY - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code LQY since 1987, with 46 receiving FDA clearance (average review time: 165 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under LQY have taken an average of 200 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.
LQY devices are reviewed by the Dental panel. Browse all Dental devices →