FDA 510(k) Application Details - K043504

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K043504
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	HERAEUS KULZER, INC. 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	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2004
Decision Date	01/28/2005
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