FDA 510(k) Application Details - K172169

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K172169
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 US Other 510(k) Applications for this Company
Contact	Kenneth J. Berk 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	07/18/2017
Decision Date	01/05/2018
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