FDA 510(k) Application Details - K192007

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K192007
Device Name	Cement, Dental
Applicant	Bisco, Inc. 1100 West Irving Park Rd. Schaumburg, IL 60193 US Other 510(k) Applications for this Company
Contact	Diana Vu 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	07/29/2019
Decision Date	03/17/2020
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