FDA 510(k) Application Details - K062502

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K062502
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	OSPRAY, LTD. 700 THIRTEENTH STREET NW SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	CARMELINA G ALLIS Other 510(k) Applications for this Contact
Regulation Number	872.6030   More FDA Info for this Regulation Number
Classification Product Code	EJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2006
Decision Date	12/15/2006
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