FDA 510(k) Application Details - K190503

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K190503
Device Name	Resin, Root Canal Filling
Applicant	Meta Biomed Co., Ltd. 270, Osong Saengmyeong 1-ro Osong-eup, Heungdeok-gu Cheongju-si 28161 KR Other 510(k) Applications for this Company
Contact	Suk Song Oh 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	03/01/2019
Decision Date	06/07/2019
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