FDA 510(k) Application Details - K233161

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K233161
Device Name	Cement, Dental
Applicant	Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 US Other 510(k) Applications for this Company
Contact	Mauro Malzyner Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	09/28/2023
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	Y
Expedited Review