FDA 510(k) Application Details - K112627

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K112627
Device Name	Device, Jaw Repositioning
Applicant	MILLENIUM DENTAL LABORATORY, INC 18056 WACO DRIVE NW RAMSEY, MN 55303 US Other 510(k) Applications for this Company
Contact	NGHIEP V NGUYEN Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2011
Decision Date	06/06/2012
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