FDA 510(k) Application Details - K181965

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K181965
Device Name	Varnish, Cavity
Applicant	Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine, CA 92604 US Other 510(k) Applications for this Company
Contact	Jiahe Li Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2018
Decision Date	06/13/2019
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