FDA 510(k) Application Details - K053040

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K053040
Device Name	Cement, Dental
Applicant	COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE NEW YORK, NY 10128 US Other 510(k) Applications for this Company
Contact	HENRY J VOGELSTEIN Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2005
Decision Date	11/09/2005
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