FDA Product Code NUN: Bone Grafting Material, Human Source
Intended To Be Packed Into Bony Voids Or Gaps To Fill And/or Augment Dental Intraosseous, Oral And Cranio-/maxillofacial Defects. These Defects May Be Surgically Creatd Osseous Defects Or Osseous Defects Created From Traumatic Injry To The Bone, Inlcuding Periodenta/infrabony Defects; Alveolar Ridge Augmentation (sinusotomy, Osteotomy, Cystectomy); Dental Extraction Sites (ridge Maintenance, Implant Preparation/placement); Sinus Lifts; Cystic Defects; Craniofacial Augmentation.
Leading manufacturers include Medtronic Sofamor Danek, Exactech, Inc. and Medtronic Sofamor Danek, Inc..
15
Total
15
Cleared
169d
Avg days
2005
Since
FDA 510(k) Cleared Bone Grafting Material, Human Source Devices (Product Code NUN)
15 devices
Cleared
Aug 12, 2011
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
Exactech, Inc.
Dental
235d
Cleared
Nov 10, 2008
PROGENIX
Medtronic Sofamor Danek
Dental
75d
Cleared
Jul 18, 2008
PROGENIX PLUS
Medtronic Sofamor Danek, Inc.
Dental
9d
Cleared
May 13, 2008
PROGENIX DBM PUTTY
Medtronic Sofamor Danek
Dental
83d