FDA 510(k) Application Details - K123876

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K123876
Device Name	Bone Grafting Material, Animal Source
Applicant	ODONTIT SA 2600 MULLINIX MILL ROAD MT AIRY, MD 21771 US Other 510(k) Applications for this Company
Contact	BLIX WINSTON Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2012
Decision Date	05/22/2014
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