FDA 510(k) Application Details - K080882

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K080882
Device Name	Material, Impression
Applicant	SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 BENSHEIM D-64625 DE Other 510(k) Applications for this Company
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2008
Decision Date	04/11/2008
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	Y
Expedited Review