FDA 510(k) Application Details - K101064

Device Classification Name	Denture, Plastic, Teeth   More FDA Info for this Device
510(K) Number	K101064
Device Name	Denture, Plastic, Teeth
Applicant	BREDENT GMBH & CO.KG SCHWARZWALDSTRASSE 5 TUTTLINGEN, BAWU 78532 DE Other 510(k) Applications for this Company
Contact	ANDREA PECSI 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	04/16/2010
Decision Date	09/14/2010
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