FDA 510(k) Application Details - K222459

Device Classification Name	More FDA Info for this Device
510(K) Number	K222459
Device Name	Centrix FluoroSilver Silver Diamine Fluoride 38%
Applicant	Centrix Inc 770 River Rd Shelton, CT 06484 US Other 510(k) Applications for this Company
Contact	Greg Moreau 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	08/15/2022
Decision Date	10/27/2023
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