FDA 510(k) Application Details - K190608

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K190608
Device Name	Bracket, Ceramic, Orthodontic
Applicant	Orthosun Co., Ltd. 2F, 112, Pyeongni-gil, Gyeyang-gu Incheon 21008 KR Other 510(k) Applications for this Company
Contact	Ju-Sung Lee Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2019
Decision Date	11/04/2019
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