FDA 510(k) Application Details - K020009

Device Classification Name	Wax, Dental, Intraoral   More FDA Info for this Device
510(K) Number	K020009
Device Name	Wax, Dental, Intraoral
Applicant	UDENT, INC. 676 FAIRPLEX DR. POMONA, CA 91768 US Other 510(k) Applications for this Company
Contact	MANAR JAMAL Other 510(k) Applications for this Contact
Regulation Number	872.6890   More FDA Info for this Regulation Number
Classification Product Code	EGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2002
Decision Date	02/11/2002
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