FDA 510(k) Application Details - K161335

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K161335
Device Name	Implant, Endosseous, Orthodontic
Applicant	JEIL MEDICAL CORPORATION 702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, DIGITAL-RO34-GIL, GURO-GU SEOUL 08378 KR Other 510(k) Applications for this Company
Contact	SEUNGYOUNG LEE Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	OAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2016
Decision Date	02/23/2017
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