FDA 510(k) Application Details - K011785

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K011785
Device Name	Material, Impression
Applicant	MANUFACTURERA DENTAL CONTINENTAL 27881 LA PAZ ROAD, #G 316 LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	GARY S MOCNIK Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2001
Decision Date	09/04/2001
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