FDA 510(k) Application Details - K161580

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K161580
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	PREMIER DENTAL COMPANY PRODUCTS 1710 ROMANO DRIVE PLYMOUTH MEETING, PA 19462 US Other 510(k) Applications for this Company
Contact	VINCENT D'ALESSANDRO Other 510(k) Applications for this Contact
Regulation Number	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2016
Decision Date	10/18/2016
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