FDA 510(k) Application Details - K062166

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K062166
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. PLYMOUTH MEETING, PA 19462 US Other 510(k) Applications for this Company
Contact	VINCE D'ALESSANDRO 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	07/28/2006
Decision Date	11/21/2006
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