FDA 510(k) Application Details - K030859

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K030859
Device Name	Powder, Porcelain
Applicant	ENAMELITE LLC 1800 BUSINESS PARK DR. SUITE 406 CLARKSVILLE, TN 37040 US Other 510(k) Applications for this Company
Contact	PHILLIP PITTS 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	03/18/2003
Decision Date	03/27/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review