FDA 510(k) Application Details - K123861

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K123861
Device Name	Implant, Endosseous, Root-Form
Applicant	AIDI BIOMEDICAL LLC 34859 FREDERICK ST #105 WILDOMAR, CA 92595 US Other 510(k) Applications for this Company
Contact	CHEN TIAN 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	12/14/2012
Decision Date	12/12/2013
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