FDA 510(k) Application Details - K053060

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K053060
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	THERMOPLASTIC COMFORT SYSTEMS, INC. 2075 E. 27TH ST. SIGNAL HILL, CA 90755 US Other 510(k) Applications for this Company
Contact	MARILIN POSCA 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	10/31/2005
Decision Date	07/20/2006
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