FDA 510(k) Application Details - K150696

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K150696
Device Name	Agent, Tooth Bonding, Resin
Applicant	Dharma Research, Inc. 5220 NW 72nd Ave #15 Miami, FL 33166 US Other 510(k) Applications for this Company
Contact	Ricardo Carles Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2015
Decision Date	06/23/2015
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