FDA 510(k) Application Details - K123512

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K123512
Device Name	Implant, Endosseous, Root-Form
Applicant	BIODENTA SWISS AG TRAMSTRASSE 16 BERNECK 9442 CH Other 510(k) Applications for this Company
Contact	DAVID EILER Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2012
Decision Date	03/28/2013
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