FDA 510(k) Application Details - K081253

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K081253
Device Name	Powder, Porcelain
Applicant	C5 MEDICAL WERKS, INC. 2451 RIVER RD. GRAND JUNCTION, CO 81505 US Other 510(k) Applications for this Company
Contact	HOMER GREGORY 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	05/02/2008
Decision Date	05/15/2008
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	Y
Expedited Review