FDA 510(k) Application Details - K082652

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K082652
Device Name	Powder, Porcelain
Applicant	BITTAR ZIRCONIA BLOCK, LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	STUART R GOLDMAN 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	09/12/2008
Decision Date	12/30/2008
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