FDA 510(k) Application Details - K150933

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K150933
Device Name	Agent, Tooth Bonding, Resin
Applicant	Heraeus Kulzer LLC, Mitsui Chemicals Group 3001 Heraeus Way South Bend, IN 46614 US Other 510(k) Applications for this Company
Contact	Jamie Cleveland 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	04/06/2015
Decision Date	07/07/2015
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