FDA 510(k) Application Details - K162856

Device Classification Name	Handpiece, Contra- And Right-Angle Attachment, Dental   More FDA Info for this Device
510(K) Number	K162856
Device Name	Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant	Bonart Co., Ltd. NO. 80, WUXUAN ST., KEELUNG CITY 20446 TW Other 510(k) Applications for this Company
Contact	Bankson Tsai Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2016
Decision Date	07/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review