FDA 510(k) Application Details - K181917

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K181917
Device Name	Resin, Root Canal Filling
Applicant	NuSmile, LTD. 3315 W 12th Street Houston, TX 77008 US Other 510(k) Applications for this Company
Contact	Alafiz Prasla 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	07/17/2018
Decision Date	01/11/2019
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