FDA 510(k) Application Details - K041312

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K041312
Device Name	Powder, Porcelain
Applicant	NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	ELIZABETH J MASON Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2004
Decision Date	07/23/2004
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