FDA 510(k) Application Details - K060844

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K060844
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	J. MORITA USA, INC. 9 MASON IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	HOWARD ROWE Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2006
Decision Date	06/06/2006
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