FDA 510(k) Application Details - K111907

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K111907
Device Name	Unit, Operative Dental
Applicant	SHANGHAI DYNAMIC INDUSTRY CO., LTD. RM 1706, NO. 128 SONGLE RD SONGJIANG AREA SHANGHAI 201600 CN Other 510(k) Applications for this Company
Contact	DORIS DONG Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2011
Decision Date	12/02/2011
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