510(k) K241041

Silver Fluoride Hypersensitivity Varnish by Young Dental Manufacturing Co. 1, LLC — Product Code PHR

K241041 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "Silver Fluoride Hypersensitivity Varnish". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.