FDA 510(k) Application Details - K092231

Device Classification Name	Denture, Plastic, Teeth   More FDA Info for this Device
510(K) Number	K092231
Device Name	Denture, Plastic, Teeth
Applicant	GEBDI DENTAL-PRODUCTS GMBH INDUSTRIESTR 3A ENGEN BAWU 78234 DE Other 510(k) Applications for this Company
Contact	THOMAS BISKUPSKI 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	07/23/2009
Decision Date	11/24/2009
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