FDA 510(k) Application Details - K133049

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K133049
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOMET 3I 4555 RIVERSIDE DRIVE PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	CHRIS MCKEE Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2013
Decision Date	01/08/2014
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