FDA 510(k) Application Details - K083701

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K083701
Device Name	Material, Impression
Applicant	KETTENBACH GMBH & CO KG 975 VERONICA SPRINGS ROAD SANTA BARBARA, CA 93105 US Other 510(k) Applications for this Company
Contact	KRISTI KISTNER Other 510(k) Applications for this Contact
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	12/15/2008
Decision Date	01/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review