FDA 510(k) Application Details - K011333

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K011333
Device Name	Powder, Porcelain
Applicant	DEGUSSA - NEY DENTAL, INC. 65 WEST DUDLEY TOWN RD. BLOOMFIELD, CT 06002 US Other 510(k) Applications for this Company
Contact	THOMAS C CAMERON 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	05/02/2001
Decision Date	08/20/2001
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