FDA 510(k) Application Details - K121093

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K121093
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	DXM CO., LTD. 55 NORTHERN BLVD. GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	JIGAR SHAH Other 510(k) Applications for this Contact
Regulation Number	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2012
Decision Date	11/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review