FDA 510(k) Application Details - K162661

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K162661
Device Name	Resin, Root Canal Filling
Applicant	tYDS Biotech Incorporation Rm. 7, 2F., No.229, Fuxing 2nd Rd Zhubei City, Hsinchu County 302 TW Other 510(k) Applications for this Company
Contact	Liang-Yu Chang 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	09/26/2016
Decision Date	04/25/2017
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