FDA 510(k) Application Details - K082180

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K082180
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL, SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	LINDA K SCHULZ 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	08/01/2008
Decision Date	12/17/2008
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