FDA 510(k) Application Details - K241041

Device Classification Name	More FDA Info for this Device
510(K) Number	K241041
Device Name	Silver Fluoride Hypersensitivity Varnish
Applicant	Young Dental Manufacturing Co. 1, LLC 13705 Shoreline Ct. East Earth City, MO 63045 US Other 510(k) Applications for this Company
Contact	Brian Prange Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2024
Decision Date	02/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review