FDA 510(k) Application Details - K123870

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K123870
Device Name	Implant, Endosseous, Root-Form
Applicant	MEGAGEN IMPLANT CO., LTD. 325 N PUENTE STREET UNIT B BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	APRIL LEE 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	12/17/2012
Decision Date	03/27/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review