FDA 510(k) Application Details - K110759

Device Classification Name	Zinc Oxide Eugenol   More FDA Info for this Device
510(K) Number	K110759
Device Name	Zinc Oxide Eugenol
Applicant	DMG USA, INC. 5 WHITCOMB AVE. AYER, MA 01432 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2011
Decision Date	06/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review