FDA 510(k) Application Details - K980986

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K980986
Device Name	Powder, Porcelain
Applicant	IVOCLAR USA, INC. 175 PINEVIEW DR. AMHERST, NY 14150 US Other 510(k) Applications for this Company
Contact	PETER P MANCUSO 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	03/17/1998
Decision Date	05/11/1998
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