FDA 510(k) Application Details - K082591

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K082591
Device Name	Material, Impression
Applicant	HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION 4315 SOUTH LAFAYETTE BLVD. SOUTH BEND, IN 46614-2517 US Other 510(k) Applications for this Company
Contact	CHERYL V ZIMMERMAN 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	09/08/2008
Decision Date	12/05/2008
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