FDA 510(k) Application Details - K082111

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K082111
Device Name	Barrier, Synthetic, Intraoral
Applicant	INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	LISA QUAGLIA Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2008
Decision Date	05/22/2009
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