FDA 510(k) Application Details - K000078

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K000078
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT 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	01/11/2000
Decision Date	05/15/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review