FDA 510(k) Application Details - K152125

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K152125
Device Name	Drill, Bone, Powered
Applicant	BONART CO., LTD. 4F-1, NO. 3 WUQUAN 1ST RD. XINZHUANG DIST. 24892 TW Other 510(k) Applications for this Company
Contact	BANKSON TSAI Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2015
Decision Date	08/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review