FDA 510(k) Application Details - K112967

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K112967
Device Name	Crown And Bridge, Temporary, Resin
Applicant	POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42 VOLCJA DRAGA 5293 SI Other 510(k) Applications for this Company
Contact	JANJA LIPUSCEK Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2011
Decision Date	08/28/2012
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