FDA 510(k) Application Details - K200614

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K200614
Device Name	Varnish, Cavity
Applicant	Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 US Other 510(k) Applications for this Company
Contact	Kirk Kimmerling 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	03/09/2020
Decision Date	06/25/2020
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