FDA Product Code NBL: Laser, Fluorescence Caries Detection
Leading manufacturers include AIOBIO Co., Ltd., Sopro and Smartooth Co., Ltd..
FDA 510(k) Cleared Laser, Fluorescence Caries Detection Devices (Product Code NBL)
About Product Code NBL - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code NBL since 2000, with 23 receiving FDA clearance (average review time: 276 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 NBL have taken an average of 460 days to reach a decision - up from 250 days historically. Manufacturers should account for longer review timelines in current project planning.
NBL devices are reviewed by the Dental panel. Browse all Dental devices →