FDA 510(k) Application Details - K033785

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K033785
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	DISCUS DENTAL, INC. 8550 HIGUERA ST. CULVER CITY, CA 90232-2522 US Other 510(k) Applications for this Company
Contact	VIVIAN LAI 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	12/04/2003
Decision Date	06/18/2004
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