FDA 510(k) Application Details - K080631

Device Classification Name	Cleanser, Denture, Over The Counter   More FDA Info for this Device
510(K) Number	K080631
Device Name	Cleanser, Denture, Over The Counter
Applicant	ORAL HEALTH TECHNOLOGIES, LLC 1062 ALLEGHENY DRIVE DANVILLE, CA 94526 US Other 510(k) Applications for this Company
Contact	ROBERT E TRICCA Other 510(k) Applications for this Contact
Regulation Number	872.3520   More FDA Info for this Regulation Number
Classification Product Code	EFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2008
Decision Date	05/23/2008
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