FDA 510(k) Application Details - K163714

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K163714
Device Name	Bone Grafting Material, Animal Source
Applicant	Datum Dental Ltd 1 Bat Sheva St., PO Box 6170 Lod 7116003 IL Other 510(k) Applications for this Company
Contact	Arie Goldlust 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	12/30/2016
Decision Date	07/18/2017
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