FDA 510(k) Application Details - K140350

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K140350
Device Name	Varnish, Cavity
Applicant	PREVENTIVE TECHNOLOGIES, INC. 4330C Matthews Indian Trail Rd Indian Trail, NC 28079 US Other 510(k) Applications for this Company
Contact	KENNETH S PETERSON Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2014
Decision Date	12/12/2014
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