FDA 510(k) Application Details - K133069

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K133069
Device Name	Handpiece, Air-Powered, Dental
Applicant	CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District SOUTHERN TAIWAN SCIENCE PARK Kaohsiung City 82151 TW Other 510(k) Applications for this Company
Contact	CHIN-TING WEN Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	10/24/2014
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