FDA 510(k) Application Details - K100539

Device Classification Name	Agent, Polishing, Abrasive, Oral Cavity   More FDA Info for this Device
510(K) Number	K100539
Device Name	Agent, Polishing, Abrasive, Oral Cavity
Applicant	PREVENTIVE TECHNOLOGIES, INC. 4330 MATHEWS-INDIAN TRAIL ROAD INDIAN TRIAL, NC 28079 US Other 510(k) Applications for this Company
Contact	KENNETH S PETERSON 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	02/25/2010
Decision Date	06/17/2010
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