FDA 510(k) Application Details - K043496

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K043496
Device Name	Unit, Operative Dental
Applicant	J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT Other 510(k) Applications for this Contact
Regulation Number	872.6640   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	12/17/2004
Decision Date	02/16/2005
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