FDA 510(k) Application Details - K112397

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K112397
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	LANG DENTAL MFG. CO., INC. P.O BOX 969 WHEELING, IL 60090-0969 US Other 510(k) Applications for this Company
Contact	DAVID LANG Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2011
Decision Date	11/04/2011
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