FDA 510(k) Application Details - K120404

Device Classification Name	Denture, Plastic, Teeth   More FDA Info for this Device
510(K) Number	K120404
Device Name	Denture, Plastic, Teeth
Applicant	MERZ DENTAL GMBH 5616 MARIOLA PL NE ALBUQUERQUE, NM 87111 US Other 510(k) Applications for this Company
Contact	RICHARD G HUNTER Other 510(k) Applications for this Contact
Regulation Number	872.3590   More FDA Info for this Regulation Number
Classification Product Code	ELM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2012
Decision Date	05/21/2012
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