FDA 510(k) Application Details - K140281

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K140281
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	EPIC MEDICAL CONCEPTS & INNOVATIONS 6950 SQUIBB RD, STE 300 MISSION, KS 66202 US Other 510(k) Applications for this Company
Contact	ALEX WALLER 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	02/04/2014
Decision Date	07/24/2014
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