FDA 510(k) Application Details - K131432

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K131432
Device Name	Agent, Tooth Bonding, Resin
Applicant	KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI CHIYODA-KU 100-0004 JP Other 510(k) Applications for this Company
Contact	MICHIO TAKIGAWA 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	05/17/2013
Decision Date	08/22/2013
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