FDA 510(k) Application Details - K152297

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K152297
Device Name	Implant, Endosseous, Orthodontic
Applicant	BOMEI CO., LTD 4F., NO.1492-2, CHUNRIH RD., TAOYUAN DIST. TAOYUAN CITY 33051 TW Other 510(k) Applications for this Company
Contact	LINNEY CHIANG 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	08/13/2015
Decision Date	02/09/2016
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