FDA 510(k) Application Details - K984427

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K984427
Device Name	Powder, Porcelain
Applicant	NEY DENTAL, INC. 1065 S.W. 30TH AVE. DEERFIELD BEACH, FL 33442-8193 US Other 510(k) Applications for this Company
Contact	ANDREW J PIETROBONO 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	12/11/1998
Decision Date	03/15/1999
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