FDA 510(k) Application Details - K110403

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K110403
Device Name	Agent, Tooth Bonding, Resin
Applicant	SILMET LTD. 12 HASSADNA ST. OR YEHUDA 60200 IL Other 510(k) Applications for this Company
Contact	MOSHE ZALSMAN 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	02/11/2011
Decision Date	09/08/2011
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