510(k) K242103

TRIOS Ready Tip by 3Shape TRIOS A/S — Product Code NBL

K242103 is an FDA 510(k) premarket notification submitted by 3Shape TRIOS A/S for the device "TRIOS Ready Tip". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. 3Shape TRIOS A/S has at least 2 other 510(k) clearances on record.