FDA 510(k) Application Details - K132937

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K132937
Device Name	Crown And Bridge, Temporary, Resin
Applicant	HARVEST DENTAL PRODUCTS, LLC 4281 EXPRESS LANE STE # L4094 SARASOTA, FL 34238 US Other 510(k) Applications for this Company
Contact	ANDREW ROWE 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	09/18/2013
Decision Date	05/21/2014
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