FDA 510(k) Application Details - K200555

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K200555
Device Name	Cement, Dental
Applicant	Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana 181133 IN Other 510(k) Applications for this Company
Contact	Atul Modi 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	03/03/2020
Decision Date	05/13/2021
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