FDA 510(k) Application Details - K102053

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K102053
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	SUNSTAR AMERICAS, INC. 10 E. SCANTON AVE SUITE 201 LAKE BLUFF, IL 60044 US Other 510(k) Applications for this Company
Contact	CARL JENKINS 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	07/22/2010
Decision Date	02/03/2011
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