FDA 510(k) Application Details - K090911

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K090911
Device Name	Device, Jaw Repositioning
Applicant	DENTAL CRAFTERS P.O. BOX 770 MARSHFELD, WI 54449 US Other 510(k) Applications for this Company
Contact	AMY NYSTROM 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	04/01/2009
Decision Date	09/11/2009
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