FDA 510(k) Application Details - K172839

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K172839
Device Name	Resin, Root Canal Filling
Applicant	Septodont 416 South Taylor Avenue Louisville, CO 80027 US Other 510(k) Applications for this Company
Contact	Jaimie Woodruff Other 510(k) Applications for this Contact
Regulation Number	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2017
Decision Date	02/13/2018
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