FDA 510(k) Application Details - K120875

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K120875
Device Name	Implant, Endosseous, Root-Form
Applicant	B&W SRL CORRIENTES 3859 BUENOS AIRES AR AR Other 510(k) Applications for this Company
Contact	PRIYA BHUTANI 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	03/22/2012
Decision Date	09/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review