FDA 510(k) Application Details - K072604

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K072604
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	09/17/2007
Decision Date	11/16/2007
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