Light-Induced Fluorescence Caries Detector

How Is NBL Classified?

Light-Induced Fluorescence Caries Detector is FDA product code NBL, Class 2, 21 CFR 872.1745.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 329 days from receipt to decision on them.