FDA 510(k) Application Details - K063444

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K063444
Device Name	Agent, Tooth Bonding, Resin
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	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2006
Decision Date	03/20/2007
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