FDA 510(k) Application Details - K250222

Device Classification Name	More FDA Info for this Device
510(K) Number	K250222
Device Name	SDF Pro
Applicant	Belport Company, Inc., Gingi-Pak 4825 Calle Alto Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	Peng Jingtian 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	01/27/2025
Decision Date	05/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review